BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUU-CHEK COMPACT TEST DRUM

    MDR report key: 1060102 · Received June 11, 2008

    Report

    Report Number
    1823260-2008-04639
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT COMPACT BLOOD GLUCOSE TEST STRIPS WERE MISSING THE LABEL THAT CONTAINS THE EXPIRATION DATE. NO ACTIONS OR TREATMENT WERE REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. NO ADVERSE EVENT REPORTED. A REQUESTED WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 20678942

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR NOVOLOG - 5.5 YEARS| LANTUS - 5.5 YEARS