BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1060835 · Received June 16, 2008

    Report

    Report Number
    1823260-2008-04767
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    June 8, 2008
    Report Date
    June 16, 2008
    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 REPORTS BACK TO BACK TESTING TO A PROFESSIONAL METER WHILE USING THE COMPACT SYSTEM WITH RESULTS OF 168MG/DL ON CUSTOMER'S METER AND 78MG/DL ON PROFESSIONAL METER. NO QUALITY CONTROL INFORMATION WAS PROVIDED. NO ADVERSE EVENT REPORTED. CUSTOMER HAS NO STRIPS TO RETURN; A 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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR PANTOPRAZOLE 40MG/DAY| B1 81MG/DAY| ADVAIR 250 MCG 2X/DAY| FLOMAX 0.4MG 2X/DAY| DETROL LA 4MG/DAY| METOPROLOL SUCCINATE 50MG/DAY| METFORMIN 1000MG 2X/DAY| FOLIC ACID 1MG/DAY| FOSINOPRIL SODIUM 20MG 3X/DAY| LIPITOR 20MG 2X/DAY