BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM BASE

    MDR report key: 1823926 · Received September 2, 2010

    Report

    Report Number
    1823260-2010-05222
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THE INFORM BASE APPEARS SCORCHED NEAR THE CONNECTER PINS, AND THAT THE BASE'S PINS HAVE MELTED TOGETHER. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE WIRE BROKE APPROXIMATELY 2MM FROM THE DISTAL END. THE WIRE BROKE INTO TWO PIECES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1