BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1781074 · Received July 25, 2007

    Report

    Report Number
    1823260-2007-06493
    Event Type
    Malfunction
    Date Received
    July 25, 2007
    Date of Event
    July 9, 2007
    Report Date
    July 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED RESULTS OF 217 MG/DL AND 92 MG/DL, OBTAINED WITHIN 10 MINUTES ON THE ACCU-CHEK COMPACT SYSTEM. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR UNITS| 70/30 HUMALOG FOR YEARS - BG 151-200MG/DL TAKES 2