BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 734085 · Received June 28, 2006

    Report

    Report Number
    1823260-2006-03152
    Event Type
    Malfunction
    Date Received
    June 28, 2006
    Date of Event
    May 31, 2006
    Report Date
    May 31, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE EXPIRATION DATE, PRINTED ON THE STRIP DRUM VIAL, IS 2006-08. ACCORDING TO THE MANUFACTURER'S ELECTRONIC INVENTORY SYSTEM, THE CORRECT EXPIRATION DATE FOR THE ASSOCIATED LOT NUMBER IS 2005-08. NO PATIENT INJURY WAS REPORTED AND NO TREATMENT WAS RECEIVED. 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 NBW ROCHE DIAGNOSTICS NA 20620441

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR METFORMIN (UNSPECIFIED) BLOOD PRESSURE MEDICATION| ACCU-CHEK COMPACT BLOOD GLUCOSE MONITOR| THERAPY DATES: UNK