BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5690092 · Received May 31, 2016

    Report

    Report Number
    2027969-2016-00406
    Event Type
    Malfunction
    Date Received
    May 31, 2016
    Date of Event
    May 3, 2016
    Report Date
    May 3, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE IN-HOUSE TESTING HISTORY OF STRIP LOT K382425 WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. ALTHOUGH A TECHNIQUE ISSUE WAS IDENTIFIED IN THE COMPLAINT WHICH MAY HAVE CONTRIBUTED TO THE DISCREPANT RESULTS OBTAINED BY THE CUSTOMER, A ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    REPORT RECEIVED OF DISCREPANT INRATIO VALUES. EVENT OCCURRED IN (B)(6). PATIENT'S THERAPEUTIC RANGE 2 - 3. ON (B)(6) 2016 PATIENT'S WIFE REPORTED DISCREPANT HIGH INRATIO RESULTS COMPARED TO LABORATORY INR RESULTS. THE PATIENT IS CURRENTLY IN A REHAB CLINIC RECOVERING FROM A STROKE EVENT. FOLLOW-UP WITH THE PATIENT'S WIFE AND REHAB CLINIC CONFIRMED THE FOLLOWING: BEFORE STROKE EVENT: THERE IS NO KNOWN EVIDENCE FOR DISCREPANT INRATIO RESULTS PRIOR TO THE STROKE. THE PATIENT'S WIFE RECALLED THEY DID ONE COMPARISON A LONGER TIME AGO AND IT WAS COMPARABLE TO THE LAB RESULTS. NO DETAILS KNOWN. STROKE EVENT: THE PATIENT WAS HOSPITALIZED DUE TO A STROKE ON (B)(6) 2016. PATIENT WAS MOVED TO THE NORMAL STATION ON (B)(6) 2016. PATIENT LEFT THE HOSPITAL ON (B)(6) 2016. IT IS REPORTED THE PATIENT HAS NO PARALYSIS, NO VERBAL DISABILITIES. A SLIGHT LOSS OF VISION (VISION AT 80%), WHICH IS RECEDING AND IMPROVING. IT IS ALLEGED BY THE PATIENT'S PHYSICIAN THAT THE PATIENT HAD A TRAUMATIC BRAIN INJURY AND - BECAUSE OF THE CARDIOGENIC SHOCK - RENAL FAILURE. THE PATIENT'S PHYSICIAN ALLEGES THAT THE PATIENT'S PHENPROCOUMON DOSAGE WAS TOO LOW BECAUSE OF THE HIGH RESULTS GIVEN BY THE INRATIO METER. (NOTE: NO INRATIO RESULTS WERE REPORTED PRIOR TO THE STROKE.) FIRST REPORTED INRATIO RESULT WAS ON (B)(6) 2016, APPROXIMATELY THREE WEEKS AFTER PATIENT'S STROKE, INRATIO INR = 2.7; LAB INR = 1.9. (B)(6) 2016 INRATIO INR = 2.2; LAB INR = 1.5. UNKNOWN DATE: THE PHYSICIAN FROM THE REHAB CLINIC REPORTED THE FOLLOWING RESULT. INRATIO INR = 4.8, LAB INR = 1.9 ALTHOUGH THE DATE WAS NOT PROVIDED, THIS RESULT WAS LIKELY POST STROKE AS IT WAS REPORTED BY THE REHAB CLINIC. ADDITIONAL RESULTS WERE TESTED ON A DIFFERENT LOT: ON (B)(6) 2016 INRATIO INR (LOT #K382425) = 4.3; INRATIO INR (LOT #K385431) = 3.8; LABORATORY INR = 2.9. ON (B)(6) 2016 INRATIO INR (LOT #K382425) = 4.2; INRATIO INR (LOT #K385431) = 3.5. NO LAB COMPARISON WAS TAKEN ON THIS UNSPECIFIED DATE. THIS EVENT IS BEING FILED AS A MALFUNCTION DUE TO THE DISCREPANT RESULTS AFTER THE STROKE EVENT. THERE IS NO INFORMATION AVAILABLE TO SUGGEST THAT THE INRATIO DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED STROKE AND SUBSEQUENT PATIENT OUTCOME. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343966 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K382425

    Patients

    Seq Age Sex Outcome Treatment
    1