BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2070524 · Received March 29, 2011

    Report

    Report Number
    2531779-2011-02043
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Report Date
    February 25, 2011
    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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. A REVIEW OF PUMP HISTORY DID NOT FIND ANY EVIDENCE OF THE LOAD STEP STOPPING SHORT. PUMP WAS LOADED AND PRIMED SEVERAL TIMES WITHOUT DUPLICATING THE COMPLAINT. DURING EVAL THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.

    Description of Event or Problem · 1

    PUMP IS RETURNED FOR SHORT LOAD STEP CAUSING A LARGE PRIME VOLUME. EVAL REVEALED AN OUT OF CALIBRATION FORCE SENSOR. THIS REPORT IS BEING MADE BASED ON THE 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 1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1