BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2594688 · Received May 31, 2012

    Report

    Report Number
    2531779-2012-04741
    Event Type
    Malfunction
    Date Received
    May 31, 2012
    Report Date
    May 4, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/04/2012 WITH THE FOLLOWING FINDINGS: THE PUMP LOAD STEP FAILED TO LOAD THE CARTRIDGE. DURING EVALUATION CONTAMINATION WAS FOUND ON THE FORCE SENSOR AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. CORRECTION: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR A LARGE PRIME VOLUME. EVALUATION REVEALED CONTAMINATION IN THE FORCE SENSOR ASSEMBLY AND AN OUT OF CALIBRATION FORCE SENSOR. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR