BEUDAMED
    FDA Adverse Event Death Summary report: N

    INRATIO2 PT/INR MONITORING SYSTEM

    MDR report key: 4888653 · Received July 2, 2015

    Report

    Report Number
    2027969-2015-00441
    Event Type
    Death
    Date Received
    July 2, 2015
    Date of Event
    June 1, 2012
    Report Date
    July 2, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS NOT POSSIBLE TO DETERMINE WHETHER THE CHANGE IN VALUE WAS DUE TO A CHANGE IN THE PATIENT'S STATUS RATHER THAN THE DEVICE, SINCE THERE WERE TWELVE (12) DAYS BETWEEN THE LAST INRATIO INR RESULT AND THE LABORATORY INR RESULT. THE PRODUCTS WERE NOT RETURNED; THEREFORE, RETAIN STRIPS WERE USED FOR INVESTIGATION TESTING. THE RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND PRECISION CRITERIA. THE ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY WITH THE INRATIO TEST STRIPS. FURTHER INVESTIGATION OF DISCREPANT LOW INRATIO RESULTS IS DOCUMENTED IN (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE SON OF A PATIENT CONTACTED ALERE (B)(4). THE SON EXPLAINED THAT HIS FATHER (A PATIENT SELF-TESTER) EXPERIENCED DISCREPANT RESULTS ON HIS INRATIO MONITOR VERSUS LABORATORY RESULTS AND HE REPORTED THE FOLLOWING INR INFORMATION: (B)(6) 2012: INRATIO=1.6. (B)(6) 2012: INRATIO=2.1. (B)(6) 2012: LAB=4.9. ON (B)(6) 2012, TWELVE DAYS AFTER THE LAST KNOWN INRATIO RESULT, THE PATIENT WAS HOSPITALIZED FOR AN INCREASED INR AND A BRAIN BLEED. HE WAS TAKEN OFF OF COUMADIN AND GIVEN VITAMIN K AT THAT TIME. THE PATIENT'S SON STATED THE PATIENT DIED ON (B)(6) 2012 OF A BRAIN BLEED. (B)(4) IS CONSERVATIVELY FILING THIS EVENT AS AN MDR WITH "DEATH" AS THE TYPE OF REPORTABLE EVENT, DESPITE THE TWELVE-DAY GAP BETWEEN THE LAST KNOWN INRATIO RESULT AND THE LABORATORY RESULT, BECAUSE THE ALLEGED INRATIO DISCREPANT RESULT CANNOT BE RULED OUT IN THESE CIRCUMSTANCES AND THE REPORTED CAUSE OF DEATH WAS A BRAIN BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432351 INRATIO2 PT/INR MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200457

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death TYLENOL| COUMADIN| INRATIO PT/INR TEST STRIPS 100071, LOT # 263072