BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE TEST STRIPS

    MDR report key: 654702 · Received December 14, 2005

    Report

    Report Number
    1823260-2005-03902
    Event Type
    Malfunction
    Date Received
    December 14, 2005
    Date of Event
    November 19, 2005
    Report Date
    November 19, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE STRIP VIAL EXPIRATION DATE, PRINTED ON THE VIAL, IS 09/2005; HOWEVER, ACCORDING TO THE MANUFACTURER'S ELECTRONIC INVENTORY, THE CORRECT EXPIRATION DATE FOR THE STRIP LOT IS 09/1999. NO PATIENT INJURY WAS REPORTED. 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 ADVANTAGE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS NA 400521

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN