BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2474688 · Received March 1, 2012

    Report

    Report Number
    2531779-2012-01690
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Report Date
    December 4, 2011
    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

    THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED ON (B)(6) 2012; 2531779-03/24/2010-003-R. DURING EVALUATION THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE PHYSICALLY DAMAGED.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR MULTIPLE LOSS OF PRIME WARNINGS. EVALUATION REVEALED A DAMAGED FORCE SENSOR ASSEMBLY. 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 14 YR