BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1162186 · Received September 16, 2008

    Report

    Report Number
    1823260-2008-06913
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS HE HAS ONE TEST STRIP DRUM CONTAINER THAT DOES NOT HAVE AN EXPIRATION DATE ON IT WHILE USING COMPACT TEST STRIPS. CUSTOMER REPORTS IT SAYS "USE BY" BUT THEN IS BLANK, LIKE IT DIDN'T GET PRINTED. NO ADVERSE EVENT REPORTED. CUSTOMER REPORTS THE CONTAINER IS ALREADY EMPTY; EMPTY DRUM IS TO BE RETURNED; A REPLACEMENT WAS SENT.

    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 20664243

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR