BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK COMPACT TEST DRUM

    MDR report key: 1083717 · Received July 24, 2008

    Report

    Report Number
    1823260-2008-05732
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 214 MG/DL, 154 MG/DL, AND 114 MG/DL. 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-CHECK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 20667941

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR HUMALOG SLIDING SCALE - 2 YEARS| HYDROCODONE 5/500MG AS NEEDED| PLAVIX 75MG 1/DAILY - 4 OR 5 YEARS| DARVOCET 650MG 4/DAILY| ACTOS 15MG 1/DAILY - 6 MONTHS AGO