BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1022668 · Received April 1, 2008

    Report

    Report Number
    1823260-2008-02912
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 1, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED METER RESULTS OF 572 MG/DL, 244 MG/DL, AND 462 MG/DL WITHIN 10 MINS ON THE COMPACT PLUS SYS. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, 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 20663441

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR JANUVIA 50MG/DAY - 2 YEARS| HUMALOG 75/25 33 UNITS IN AM - 15-20 IN PM -15 YRS| OMEPRAZOLE 40MG/DAY - 2 YEARS| PRAVASTATIN 40MG/DAY - 5 YEARS| LISINOPRIL 20 MG/DAY - 6 MONTHS