BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1243245 · Received November 7, 2008

    Report

    Report Number
    1823260-2008-08231
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BLOOD GLUCOSE RESULT OF 61 MG/DL ON THE COMPACT PLUS SYSTEM, SELF-TREATED SYMPTOMS BY DRINKING JUICE. SHE REPORTED SHE THEN HAD BLOOD GLUCOSE RESULTS OF 150 MG/DL AND 83 MG/DL ON THE SAME SYSTEM WITHIN 10 MINS OF THE 61 MG/DL. CUSTOMER REPORTED NO ADDITIONAL SYMPTOMS, DID NOT TREAT OR ACT FURTHER ON RESULTS. NO ADVERSE EVENT REPORTED. STRIPS NOT AVAILABLE FOR RETURN, REPLACEMENT SYSTEM 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 72 YR LANTUS 23 UNITS/DAY - 8 YEARS| HUMALOG - 8 YEARS| "ARMOUR TRPROID" 60 MG/DAY- 5-6 MONTHS