BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2842559 · Received November 21, 2012

    Report

    Report Number
    2531779-2012-13839
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE REWIND, LOAD AND PRIME STEPS WERE PERFORMED SUCCESSFULLY WITH NO ALARMS. A CARTRIDGE WITH 100 UNITES WAS CORRECTLY LOADED INTO THE PUMP. A FORCE SENSOR CALIBRATION TEST REVEALED THE SENSOR IS NOT DETECTING CORRECT FORCE. THE RESISTANCE ON THE FORCE SENSOR WAS MEASURED AND FOUND TO BE OUT OF SPECIFICATIONS. THE PUMP WAS OPENED AND CONTAMINATION WAS FOUND ON THE FORCE SENSOR SHIM. NO BURR WAS OBSERVED ON THE PISTON ROD.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE FORCE SENSOR WAS NOT DETECTING CORRECT FORCE. THERE WAS CONTAMINATION FOUND ON THE FORCES SENSOR SHIM. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR