BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST STRIPS

    MDR report key: 1230926 · Received November 6, 2008

    Report

    Report Number
    1823260-2008-08226
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 29, 2008
    Report Date
    November 6, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 17 MG/DL AND 162 MG/DL ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES. NO TREATMENT INFO PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - NA LFR ROCHE DIAGNOSTICS CORP. 206867

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK