BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 840187 · Received February 22, 2007

    Report

    Report Number
    1823260-2007-01538
    Event Type
    Malfunction
    Date Received
    February 22, 2007
    Date of Event
    January 30, 2007
    Report Date
    February 22, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPACT TEST DRUM IS THE SUSPECT DEVICE.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE EXPIRATION DATE PRINTED ON THE COMPACT STRIP DRUM VIAL IS 2008/12. ACCORDING TO THE MANUFACTURER, THE CORRECT EXPIRATION DATE FOR THIS STRIP LOT IS 2006/12. NO PATIENT INJURY RESULTED FROM USE OF THE SUSPECT TEST STRIPS. PATIENT DID NOT PROVIDE THE LOCATION WHERE THE LABELING PROBLEM WAS FIRST DISCOVERED. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED.

    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 * 20642441

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR METFORMIN 500 MG| HUMULIN 70/30