BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1780349 · Received September 12, 2007

    Report

    Report Number
    1823260-2007-07962
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    August 22, 2006
    Report Date
    September 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER OBTAINED RESULTS OF 160MG/DL AND 40MG/DL WITHIN 10 MIN ON THE ACCU-CHEK COMPACT PLUS SYSTEM. NO ACTION WAS TAKEN BASED ON THE READINGS. 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 67 YR LANTUS 16 UNITS A DAY - 2 1/2 YRS| HUMALOG SLIDING SCALE, 3/DAY - "LONG TIME"