BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2072816 · Received March 31, 2011

    Report

    Report Number
    2531779-2011-02117
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. A REVIEW OF PUMP'S HISTORY SHOWED MULTIPLE LOSS OF PRIME ALARMS DUE TO LOW NON ZERO FORCE. DURING EVAL, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.

    Description of Event or Problem · 1

    PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED AN OUT OF CALIBRATION FORCE SENSOR. THIS REPORT IS BEING MADE BASED ON EVAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1