BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2023828 · Received February 14, 2011

    Report

    Report Number
    2531779-2011-00875
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 18, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL WILL BE CONDUCTED AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THERE WAS AN ABNORMAL PRODUCTION OF AIR BUBBLES WHEN THE CARTRIDGE WAS FILLED WITH INSULIN. THE DISTRIBUTOR SAID THAT THREE CARTRIDGES OF THE SAME LOT NUMBER ALL PRODUCED HIGH QUANTITIES OF AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN CARTRIDGE LZG ANIMAS CORP. IR 1200 / 1250 / 2020 / OTP B201509

    Patients

    Seq Age Sex Outcome Treatment
    1