BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1770695 · Received October 29, 2007

    Report

    Report Number
    1823260-2007-09423
    Event Type
    Malfunction
    Date Received
    October 29, 2007
    Date of Event
    October 13, 2007
    Report Date
    October 29, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED BLOOD GLUCOSE RESULTS OF 514 MG/DL, 186 MG/DL, 188 MG/DL AND 180 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON THE COMPACT PLUS SYSTEM. CUSTOMER REPORTED HAVING NO SYMPTOMS. CUSTOMER DID NOT TREAT OR ACT ON RESULTS. NO SERIOUS ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 20663541

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR HUMALOG - 20 YRS, BLOOD GLUCOSE OVER 150 - 1 UNIT| LYRICA - 2 YEARS, 75 MG TWICE DAILY| ACTOS - 1 YEAR, 1 YEAR, 45 MG DAIL| MELOXICAM - 7.5 MG DAILY| LISINOPRIL HCTZ - 10 YEARS, 20/25 MG DAILY| HUMALOG - 20 YRS, BLOOD GLUCOSE OVER 300 - 2 UNIT| ZETIA - 2 YEARS, 10 MG DAILY| LANTUS - 20 YEARS, 16 UNITS TWICE DAILY| METFORMIN - 20 YEARS, 500 MG TWICE DAILY