BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT STRIPS

    MDR report key: 694295 · Received March 29, 2006

    Report

    Report Number
    1823260-2006-01420
    Event Type
    Malfunction
    Date Received
    March 29, 2006
    Date of Event
    March 8, 2006
    Report Date
    March 8, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THAT THE DRUM CONTAINER HAS THE EXPIRATION DATE OF 2005-8 WHILE THE BOX IT WAS PACKAGED IN HAS THE EXPIRATION DATE OF 2006-10. THE LOT NUMBERS DO NOT CORRESPOND TO EACH OTHER. REQUESTED RETURN OF SUSPECT VIAL AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT STRIPS BLOOD GLUCOSE MONITORING LFR ROCHE DIAGNOSTICS NA 20620943

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR