BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM METER

    MDR report key: 2991036 · Received March 6, 2013

    Report

    Report Number
    1823260-2013-01332
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    CALLER STATED THAT THERE ARE SIGNS OF BURNING ON THE CONNECTOR PINS OF THE INFORM METER. CALLER STATED THE 4TH AND 5TH PIN FROM THE RIGHT LOOK BURNT AND 2 PINS TO THE FAR LEFT LOOK BURNT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94943 ACCU-CHEK ® INFORM METER BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1