BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1761235 · Received July 23, 2007

    Report

    Report Number
    1823260-2007-06420
    Event Type
    Malfunction
    Date Received
    July 23, 2007
    Date of Event
    July 2, 2007
    Report Date
    July 23, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES CUSTOMER REPORTEDLY RECEIVED RESULT IN THE 300'S (MG/DL) AND RESULT OF 170MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 20659541

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR GLIPIZIDE XL 10MG TWICE DAILY - "QUITE A WHILE"| LOTREL 5/20MG ONCE DAILY| VYTORIN 10/40MG ONCE DAILY| METFORMIN 850MG 3 TIMES DAILY - 6 YEARS| AVANDIA 4MG TWICE DAILY - FEW YEARS| BABY ASPIRIN 81MG