BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2254196 · Received September 19, 2011

    Report

    Report Number
    2531779-2011-06891
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); 2531779-03/24/2010-003-R. EVALUATION REVEALED AN OUT OF CALIBRATION FORCE SENSOR AND CONTAMINATION IN THE FORCE SENSOR ASSEMBLY. DURING TESTING, THE PUMP DID NOT RECOGNIZE A FILLED CARTRIDGE.

    Description of Event or Problem · 1

    EVALUATION REVEALED AN OUT OF CALIBRATION FORCE SENSOR AND CONTAMINATION IN THE 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 80 YR