BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM METER

    MDR report key: 2912661 · Received January 14, 2013

    Report

    Report Number
    1823260-2013-00260
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 11, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    FIRST LEVEL INVESTIGATION UNIT REPRESENTATIVE REPORTED THAT THE METER HAD SIGNS OF MELTING/BURNING. THE CONTACT PINS ARE CHARRED AND THE SURROUNDING PLASTIC AREA IS MELTED. NO ACTIONS TAKEN BASED ON DEVICE. NO ADVERSE EVENT REPORTED. DEVICE WAS RETURNED AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19754 ACCU-CHEK ® INFORM METER BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1