BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1123936 · Received August 15, 2008

    Report

    Report Number
    1823260-2008-06260
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 458 MG/DL AND 178 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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 20680441

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR METFORMIN 500MG DAILY| GLIPIZIDE 10MG DAILY| PRECOSE 100MG 3/DAILY| LANTUS 25 UNITS 2/DAILY| AVANDIA 8MG DAILY