BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM METER

    MDR report key: 1040940 · Received May 2, 2008

    Report

    Report Number
    1823260-2008-03723
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    February 27, 2008
    Report Date
    May 2, 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 OTHER COUNTRY.

    Description of Event or Problem · 1

    THE MFR'S EVAL OF THE RETURNED INFORM METER REVEALED THAT THE DEVICE'S INTERNAL CONTACTS HAD MELTED. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK INFORM METER BLOOD GLUCOSE MONITORING DEVICE - NA NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK