BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1033178 · Received April 23, 2008

    Report

    Report Number
    1823260-2008-03485
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT SHE OBTAINED THE BLOOD GLUCOSE COMPARISON OF 377MG/DL AND 134MG/DL ON THE ACCU-CHEK COMPACT PLUS SYSTEM. THE RESULTS WERE OBTAINED WITH A 10 MINUTE TIMEFRAME. NO ACTIONS TAKEN OR TREATMENT GIVEN BASED ON THE BLOOD GLUCOSE RESULTS. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 20675941

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HUMALOG 81 UNITS/DAY| LANTUS 95 UNITS/DAY