BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1922003 · Received December 8, 2010

    Report

    Report Number
    2531779-2010-02748
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS. A REVIEW OF PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED, BUT WAS NOT DUPLICATED DURING TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP EMITTED A "CARTRIDGE NOT DETECTED" WARNING THREE TIMES IN ONE WEEK. THE PT STATED THAT EACH TIME THE PUMP LOST PRIME AND HE REPLACED THE CARTRIDGE. HE SAID THAT HE RECEIVED THE "CARTRIDGE NOT DETECTED" MESSAGE. THE PT NOTED THAT THE PUMP IS TAKING A LONG TIME TO LOAD THE CARTRIDGE AND TO PRIME; HE USED A LOT OF INSULIN TO PRIME THE TUBING. HE DENIED ANY RELEVANT ALARMS IN THE HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR