BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM METER

    MDR report key: 2100994 · Received May 24, 2011

    Report

    Report Number
    1823260-2011-02760
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    UPON INVESTIGATION, MANUFACTURER'S DOMESTIC EVALUATIONS LAB FOUND MELTED PLASTIC AROUND INFORM ELECTRICAL CONTACT PINS. NO ADVERSE EVENT REPORTED. THE DEVICE WAS RETURNED, REPLACEMENT SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1