BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2136994 · Received June 22, 2011

    Report

    Report Number
    2531779-2011-04365
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED ON THE RESULTS OF INVESTIGATION COMPLETED ON 05/25/2011. (B)(6); 2531779-03/24/2010-003-R. DURING EVALUATION, THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED. A REVIEW OF THE PUMP BLACK BOX HISTORY REVEALED 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 A DAMAGED FORCE SENSOR ASSEMBLY. 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