BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM

    MDR report key: 1885037 · Received October 28, 2010

    Report

    Report Number
    1823260-2010-06390
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS INFORM METER HAS BLACKENED AND MELTED CONNECTOR PINS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    SPECTRUM PUMP ALARMED FOR PUMP FAILURE, THEN SHUT DOWN WITH MESSAGE ON SCREEN "READY". A 1.3 INSULIN WAS RUNNING AT THE TIME IT SHUT DOWN. THERE WAS NO HARM TO PATIENT.

    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