BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM

    MDR report key: 1842967 · Received September 23, 2010

    Report

    Report Number
    1823260-2010-05657
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 23, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    UPON INVESTIGATION, MANUFACTURER'S DOMESTIC EVALUATIONS LAB FOUND EVIDENCE OF ELECTRICAL SHORT, MELTING, BURNING AROUND INFORM METER 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 BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1