BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2320643 · Received November 2, 2011

    Report

    Report Number
    2531779-2011-08181
    Event Type
    Malfunction
    Date Received
    November 2, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON 10/06/2011 WITH THE FOLLOWING FINDINGS: THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED. THE PUMP SUCCESSFULLY REWOUND, LOADED AND PRIMED AND WAS EXERCISED FOR 24 HOURS WITH NO ISSUES. (B)(6). CORRECTION/REMOVAL REPORTING NUMBER: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON 10/06/2011 WITH THE FOLLOWING FINDINGS: THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED. THIS REPORT IS BEING MADE BASED ON EVALUATION RESULTS.

    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 69 YR