BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1910819 · Received November 22, 2010

    Report

    Report Number
    2531779-2010-02447
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 21, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED THAT THE FORCE SENSOR RESISTANCE READING WAS OUT OF CALIBRATION. REVIEW OF THE PUMP HISTORY REVEALED LOSS OF PRIME ALARMS. THE PUMP WAS PRIMED AND EXERCISED SUCCESSFULLY WITH NO ALARMS OCCURRING.

    Description of Event or Problem · 1

    EVAL 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