BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM

    MDR report key: 1843914 · Received September 24, 2010

    Report

    Report Number
    1823260-2010-05689
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 24, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE INFORM METER HAS A BATTERY CRITICALLY LOW AND THE GREEN LIGHT WILL NOT COME ON WHEN IT IS DOCKED. CUSTOMER NOTICED THAT THE PINS LOOKED DISCOLORED AND A FEW PINS WERE MISSING. UPON REVIEW BY THE INVESTIGATION UNIT, IT WAS DISCOVERED THAT PINS 3 AND 4 WERE MELTED AND BURNED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS 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