BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1003455 · Received February 21, 2008

    Report

    Report Number
    1823260-2008-01745
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A BLOOD GLUCOSE RESULT OF 173 MG/DL ON THE COMPACT PLUS SYSTEM BACK TO BACK WITH A RESULT OF 71 MG/DL WHEN TESTING WAS PERFORMED WITHIN 1 MINUTE OF EACH OTHER. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR HUMALOG, 4 YRS - SLIDING SCALE| LANTUS, 4 YRS - 30 UNITS ONCE DAILY