BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2925012 · Received January 22, 2013

    Report

    Report Number
    2531779-2013-00981
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    December 26, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):A REWIND AND LOAD STEP WERE PERFORMED AND DURING THE LOAD CARTRIDGE STEP THE PUMP FAILED TO DETECT THE CARTRIDGE AND EMITTED A NO CARTRIDGE DETECTED. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION AND CONTAMINATION WAS FOUND IN THE FORCE SENSOR ASSEMBLY. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR THE LOAD STEP STOPPING SHORT. INVESTIGATION REVEALED CONTAMINATION IN THE FORCE SENSOR ASSEMBLY AND AN OUT OF CALIBRATION FORCE SENSOR. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31005 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR