BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1234105 · Received November 4, 2008

    Report

    Report Number
    1823260-2008-08138
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    September 19, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    UDI-DI
    03149072001
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINED A 167MG/DL ON THE ACCU-CHEK COMPACT SYSTEM IN COMPARISON TO THE LAB RESULT OF 76MG/DL. THE RESULTS WERE OBTAINED WITHIN A TEN MIN TIMEFRAME. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. 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 ROCHE DIAGNOSTICS 20675641 03149072001

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR