FDAble Icon
 
☎ (860) 368-0332


 
 




 

 

to

 




Searched for MAUDE Adverse Events with narratives containing the term: antiphospholipid and found more than 100 results.
Brand Name Manufacturer Event Date Patient Outcome Patient Narrative
PROTIME MICROCOAGULATION SYSTEM INTERNATIONAL TECHNIDYNE CORPORATION HEALTH PROFESSIONAL REPORTS: THREE CONSECUTIVE PROTIME SYSTEM INR ERROR MESSAGE: OUT OF RANGE HIGH. UNSPECIFIED LAB SYSTEM INR RESULT 2.0. TWO CONSECUTIVE PROTIME SYSTEM INR ERROR MESSAGE: OUT OF RANGE HIGH FOLLOWED BY CONSECUTIVE INR RESULTS 1.4...
PROSORBA COLUMN CYPRESS BIOSCIENCE, INC. 07/25/00 A PT WITH SEVERE RHEUMATOID ARTHRITIS REC'D 6 PROSORBA COLUMN TREATMENTS. THE PT WAS HOSPITALIZED 24 TO 48 HOURS AFTER LAST TREATMENT. A DIAGNOSIS OF 5 PULMONARY EMBOLI WAS MADE WITH UNKNOWN LOCATION OF ORIGINATING CLOT. PT HAS NO KNOWN HISTORY OF...
COAGU CHEK XS ROCHE INSULIN DELIVERY SYSTEM, INC. 02/01/12 (B)(6) 2012, FOUND OUT FROM ROCHE TECHNICIAN THAT THE MONITOR SHE HAS BEEN USING FOR FIVE YEARS IS NOT GOOD WITH HER DIAGNOSIS OF ANTIPHOSPHOLIPID SYNDROME. SHE HAS BEEN GETTING THE WRONG RESULTS FROM THE MONITOR WHICH MOST LIKELY CAUSED HER TO...
INRATIO HEMOSENSE, INC. 01/22/07 CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 01/05/07, INRATIO: 6.1, LAB: 3.8. DATE: 01/15/07; INRATIO: 4.3; LAB: 2.8. PT HAS ANTIPHOSPHOLIPID ANTIBODY SYNDROME (CARDIOLIPIN-POSITIVE, LUPUS-NEGATIVE)....
ENDEAVOR RX DRUG-ELUTING CORONARY STENT SYSTEM MEDTRONIC CARDIOVASCULAR GALWAY 11/08/09 (SECONDARY INTERVENTION: THROMBUS ASPIRATION) - EVAL RESULTS: ANTIPHOSPHOLIPID SYNDROME. STENT THROMBOSIS. DIRECT STENTING. A 3.5MM DIAMETER X 18MM LENGTH ENDEAVOR RX DRUG-ELUTING CORONARY STENT WAS DEPLOYED IN TO A PT. THE TARGET LESION WAS...
INRATIO2 ALERE SAN DIEGO, INC. 02/21/11 INVESTIGATION PENDING. "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011; INRATIO2: 2.2; LAB: 1.9. DATE: FOLLOWING WEEK; INRATIO2: 3.1; LAB: 2.3. LAB AND METER TESTS WERE DONE WITHIN 5 MIN OF EACH...
PHILIPS HEALTHCARE 11/30/15 PATIENT WITH HISTORY OF SYSTEMIC LUPUS ERYTHEMATOSUS VASCULITIS ANTIPHOSPHOLIPID ANTIBODY SYNDROME WAS UNDERGOING LOWER EXTREMITY ULTRASOUND TO RULE OUT THROMBOSES. THE ULTRASOUND TECHNICIAN WAS ONLY ABLE TO PERFORM A LIMITED EXAM DUE TO DEGRADED...
PROTIME MICROCOAGULATION SYSTEM INTERNATIONAL TECHNIDYNE CORP. 10/23/13 A PATIENT SELF-TESTER REPORTS RESULTS HIGHER THAN REFERENCE WERE GENERATED WITH THE PROTIME MICROCOAGULATION SYSTEM. PATIENT'S THERAPEUTIC RANGE: 2.5-3.5 INR. ON (B)(6) 2014, A PATIENT SELF-TESTER REPORTED THAT HIS PROTIME INSTRUMENT GENERATED A...
COAGUCHEK ® XS SYSTEM ROCHE DIAGNOSTICS 11/07/16 NO CUSTOMER MATERIAL WAS RECEIVED FOR INVESTIGATION. THE DIFFERENCE BETWEEN THE INR VALUES OBTAINED ON THE METER AND IN THE LABORATORY CANNOT BE FURTHER ASSESSED BECAUSE THE LABORATORY METHOD IS UNKNOWN. THE PRESENCE OF ANTIPHOSPHOLIPID ANTIBODIES...
GEL IMPLANTS (BREAST) UNK STATUS POST BILATERAL SUBGLANDULAR INFRAMAMMARY GELS (UNK SIZE/MFR-NO RECORDS) FOR AUGMENTATION. THE PT BELIEVES THEY HAVE DECREASED IN SIZE. NO HISTORY OF TRAUMA AND THE RIGHT IS BURNING IN RECENT YRS WHILE THE LEFT IS "QUITE SENSITIVE." PT ALSO...
SPECTRA OPTIA TERUMO BCT 03/09/15 THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH AN EVENT OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED APPROPRIATELY IN THE MDR FORM. THIS SUPPLEMENT IS BEING FILED TO MODIFY INFORMATION...
COAGUCHEK ® XS SYSTEM ROCHE DIAGNOSTICS 01/25/16 NA THE CUSTOMER REPORTED THAT WHILE USING HER COAGUCHEK XS (SERIAL NUMBER (B)(4)) SHE OBTAINED A RESULT OF 1.4 INR AT 11:30 AM AND THEN USING A DIFFERENT FINGER AT 2:38 PM SHE OBTAINED A RESULT OF 3.2 INR. THERE WERE NO CHANGES MADE TO HER...
INRATIO HEMOSENSE, SJ 01/14/08 DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: EARLY 2007, INRATIO: 2.1, LAB: 8.5, MEAN: 5.3, CONFIDENCE LIMITS: UNABLE TO BE DETERMINED. PER INTERNAL PROCEDURE,...
INRATIO BIOSITE INCORPORATED 10/02/09 CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2009, INRATIO: 3.6, 3.6, LAB: 2.5, 2.7. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS...
INRATIO BIOSITE 01/22/09 CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH LAB. RESULTS AS FOLLOWS: DATE: 2009, INRATIO: 4.0, LAB: 2.6. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2009,...
HEARTMATE II LVAS THORATEC CORP. 06/27/14 THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVIC (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS ADMITTED WITH SUSPECTED PUMP THROMBUS. THE PT PRESENTED WITH NAUSEA AND VOMITING, AN ELEVATED LACTATE DEHYDROGENASE (LDH)...
HEARTMATE II LVAS THORATEC CORPORATION 03/10/16 THE REPORT OF PUMP THROMBOSIS COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PATIENT¿S PUMP WAS NOT EXPLANTED FOLLOWING THE PATIENT'S EXPIRATION. THE INSTRUCTIONS FOR USE DEVICE THROMBOSIS AS A POTENTIAL ADVERSE EVENT...
HEARTMATE II LVAS, EUROPE THORATEC CORP. 12/31/13 THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROX 3 DAYS POST-IMPLANT OF (B)(4), IT WAS REPORTED THAT THE PT HAD AN INCREASE IN BILIRUBIN. AN ECHOCARDIOGRAM INDICATED THAT THE AORTIC VALVE WAS OPENING WITH EVERY BEAT AND...
COAGUCHEK ® XS SYSTEM ROCHE DIAGNOSTICS 10/23/17 (B)(4). THE CUSTOMER RECEIVED AN ERROR MESSAGE INDICATING AN ISSUE APPLYING BLOOD TO THE TEST STRIP AND RECEIVED A QUESTIONABLE LOW RESULT FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE RESULT AT 11:53 AM WAS 2.2 INR AND THE RESULT AT 2 PM FROM...
COAGUCHEK ® XS SYSTEM ROCHE DIAGNOSTICS 11/07/17 (B)(4) THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE CUSTOMER STATED HE TESTED HIS MOTHER-IN-LAW AT 7:38 PM AND RECEIVED RESULT OF >8.0 INR. HE THEN TESTED HIMSELF AT 7:41 PM AND RECEIVED A RESULT OF...
COAGUCHEK ® XS SYSTEM ROCHE DIAGNOSTICS 11/10/17 THE CUSTOMER COMPLAINED OF ERRONEOUS INR RESULTS ON COAGUCHEK XS METER WITH SERIAL NUMBER (B)(4). THE CUSTOMER INITIALLY TESTED AT 7:03 A.M. WITH A RESULT OF 2.2 INR. THE CUSTOMER TESTED TWO MORE TIMES WITH A RESULT OF 1.7 INR AT 7:05 A.M. AND A...
COAGUCHEK ® XS SYSTEM ROCHE DIAGNOSTICS 12/07/17 (B)(4). THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL (B)(4) FOR ONE PATIENT. (B)(6). THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE THERAPEUTIC RANGE WAS 2-3 INR. THE PATIENT WAS ANEMIC WITH A HEMATOCRIT OF 32% ON...
COAGUCHEK ® XS SYSTEM ROCHE DIAGNOSTICS 11/07/17 THE CUSTOMER'S DAUGHTER STATED THEY RECEIVED A QUESTIONABLE RESULT FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE RESULT FROM THE METER WAS 4.0 INR AND THEN 10 MINUTES LATER, THE RESULT WAS 2.7 INR. THE RESULT OF 4.0 INR WAS AN APPROXIMATE...
COAGUCHEK ® XS SYSTEM ROCHE DIAGNOSTICS 04/06/17 THE CUSTOMER RECEIVED A QUESTIONABLE RESULT FROM HIS COAGUCHEK XS METER SERIAL NUMBER (B)(4). ON (B)(6) 2017, THE RESULT FROM THE METER WAS 2.6 INR. ON (B)(6) 2017, HE ATTEMPTED TO USE THE METER AND IT SHUT OFF. THE CUSTOMER WENT TO THE HOSPITAL...
COAGUCHEK ® XS SYSTEM ROCHE DIAGNOSTICS 04/26/16 ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION; HOWEVER, NO SUSPECT PRODUCT WAS RETURNED TO COMPLETE THE INVESTIGATION. THE COMPLAINT HAS NOT BEEN SUBSTANTIATED. . THE POINT OF CARE COORDINATOR INDICATED THAT A HIGH RESULT WAS OBTAINED ON...
COAGUCHEK ® XS SYSTEM ROCHE DIAGNOSTICS 01/12/16 THE CUSTOMER REPORTED OBTAINING A 5.5 INR COMPARED TO A 4.2 INR ON HER COAGUCHEK XS (SERIAL NUMBER (B)(4)). NO CHANGES WERE MADE TO THE CUSTOMER'S MEDICATION BASED ON THE METER RESULT. SHE IS NOT ON ANY HEPARIN OR DIRECT THROMBIN INHIBITORS. SHE...
COAGUCHEK ® XS SYSTEM ROCHE DIAGNOSTICS 11/05/15 THE CUSTOMER NO LONGER HAS THE STRIPS. THE CUSTOMER REPORTED OBTAINING A 3.2 INR AR 6:44 PM. HER THERAPEUTIC RANGE IS 2.5-3.5 SO NO CHANGES WERE MADE TO HER MEDICATION IN RESPONSE TO THE METER RESULT. SHE REPORTS PASSING OUT FOUR HOURS LATER AND...
SUPER POLIGRIP ORIGINAL DENTURE CREAM GLAXOSMITHKLINE THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF STROKE IN A (B)(6) FEMALE PT WHO RECEIVED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM ((B)(4)) ONCE DAILY AS PER DIRECTIONS FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH...
ONYX AVM MEDTRONIC 05/06/14 MEDTRONIC RECEIVED INFORMATION THAT ONYX EXTRAVASATION OCCURED DURING AN EMBOLIZATION OF DURAL FISTULA. THE PATIENT WAS TREATED FOR AN A TYPE III DURAL FISTULA OF THE ANTERIOR CRANIAL BASE LOCATED DEEP IN THE HEMISPHERIC.THE DISTAL END OF THE...
INRATIO PT/INR TEST STRIPS ALERE SAN DIEGO, INC. 03/25/15 INVESTIGATION/CONCLUSION: IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING WAS PERFORMED. THE CUSTOMER REPORTED A PRECISION ISSUE ON LOT#...