BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2135347 · Received June 21, 2011

    Report

    Report Number
    2531779-2011-04308
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED ON THE RESULTS OF INVESTIGATION COMPLETED ON 06/06/2011. (B)(6). RECALL 2531779-03/24/2010-003-R. THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/06/2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS NOT DUPLICATED DURING TESTING.

    Description of Event or Problem · 1

    PUMP IS RETURNED FOR MULTIPLE LOSS OF PRIME ALARMS. EVALUATION REVEALED PARTIALLY DISLODGED FORCE SENSOR PINS. THIS REPORT IS BEING MADE BASED ON THE 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