BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1850060 · Received September 28, 2010

    Report

    Report Number
    2531779-2010-01370
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 29, 2010
    Report Date
    August 29, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. DURING EVAL, THE FORCE SENSOR HOUSING PLATE WAS FOUND TO BE DAMAGED. FURTHER, THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.

    Description of Event or Problem · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PT REPORTED THAT THE PUMP PRODUCED MULTIPLE LOSS OF PRIME WARNINGS AND DISPENSED INSULIN, DURING THE LOAD CARTRIDGE PHASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR