BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1913523 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02552
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED THAT THE FORCE SENSOR PLATE WAS DAMAGED. EVAL ALSO REVEALED THAT THE FORCE SENSOR RESISTANCE READING WAS OUT OF CALIBRATION. THE "EZPRIME" FUNCTIONS WERE PERFORMED SUCCESSFULLY SEVERAL TIMES WITH NO ALARMS OCCURRING.

    Description of Event or Problem · 1

    EVAL REVEALED THAT THE FORCE SENSOR PLATE WAS DAMAGED. EVAL ALSO REVEALED THAT THE FORCE SENSOR RESISTANCE READING WAS OUT OF CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR