BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1771261 · Received February 15, 2008

    Report

    Report Number
    1823260-2008-01573
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    December 11, 2007
    Report Date
    February 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE EXPIRATION DATE ON THE COMFORT CURVE TEST STRIPS WAS A USABLE DATE OF 11/30/07; HOWEVER, THE DOMESTIC MANUFACTURER'S INVENTORY SYSTEM INDICATED THE STRIPS WERE EXPIRED WITH A DATE OF 11/30/04. THE MANUFACTURERS BATCH RECORDS CONFIRMED THE TEST STRIP EXPIRATION DATE IS 11/30/04. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT WAS RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE, AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 546565

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR OMEPRAZOLE - 20MG ONCE DAILY| NAPROXEN - 550MG EVERY 12 HOURS| METFORMIN - 4 YEARS - 850 MG TWICE DAILY| GLIPIZIDE - 4 YEARS - 80MG TWICE DAILY| ASPIRIN - 4 YEARS - DOSE UNKNOWN - 'DAILY"