BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1012423 · Received March 13, 2008

    Report

    Report Number
    1823260-2008-02378
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 300 MG/DL AND 105 MG/DL WITHIN 10 MINUTES ON THE COMPACT 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 20659441

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR CRESTOR 10 MG 1/DAY- 1 YEAR| METFORMIN 1000 MG 2/DAY - 2 YEARS| ACTOS 30 MG 1/DAY - 1 YEAR| MICARDIS 40 MG 1/DAY- 1 YEAR