BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1181584 · Received September 25, 2008

    Report

    Report Number
    1823260-2008-07177
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    CALLER REPORTEDLY RECEIVED BLOOD GLUCOSE RESULTS OF 265 MG/DL AND 120 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. NO ADVERSE EVENT RELATED TO THE DEVICE REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER THE CUSTOMER DID NOT RETURN THE TEST STRIPS; 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-NA NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK