BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2002664 · Received February 9, 2011

    Report

    Report Number
    2531779-2011-00707
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    ANIMAS CORP.
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. ANIMAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. A REVIEW OF THE PUMP HISTORY INDICATED A LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. EVAL REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE PUMP ALARMED "CARTRIDGE NOT DETECTED" DURING THE LOAD CARTRIDGE STEP. SHE STATED THAT THE PUMP PUSHED OUT ENTIRE CARTRIDGE OF INSULIN DURING THIS STEP WHILE THE PT WAS DISCONNECTED FROM THE INFUSION SITE. THE PT SAID SHE CHANGED TO ANOTHER NEW CARTRIDGE AND THIS TIME SHE STOPPED THE PUMP WHILE IT WAS PUSHING OUT ALL OF THE INSULIN DURING THE LOAD CARTRIDGE STEP. SHE DENIED ANY KNOWN TRAUMA TO THE PUMP OR PREVIOUS ISSUES DURING THE EZPRIME STEPS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR