BEUDAMED
    FDA Adverse Event Other Summary report: N

    PT/INR TEST STRIPS

    MDR report key: 3842887 · Received May 27, 2014

    Report

    Report Number
    MW5036367
    Event Type
    Other
    Date Received
    May 27, 2014
    Report Date
    May 26, 2014
    Manufacturer
    ALERE
    Product Code
    GJS
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    GAVE LOWER INR TOTALS, THEREBY REQUIRING AN INCREASE IN ANTICOAGULANT DOSAGE WHICH RESULTED IN AN ACTUAL OVERDOSE CAUSING A BLEEDING POTENTIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310452 PT/INR TEST STRIPS PT/INR TEST STRIPS GJS ALERE 332959

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR