BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1882459 · Received October 21, 2010

    Report

    Report Number
    2531779-2010-01758
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    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
    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 EVALUATION. A REVIEW OF THE PUMP HISTORY INDICATED THAT INTERMITTENT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. EVALUATION REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS.

    Description of Event or Problem · 1

    THE PT REPORTED THAT INSULIN PUSHED OUT OF THE PUMP DURING AN EZPRIME PHASE OF A ROUTINE CARTRIDGE AND INFUSION SET CHANGE ABOUT ONE MONTH PRIOR TO THIS REPORT. HE NOTED THAT HE REC'D MULTIPLE RANDOM LOSS OF PRIME WARNINGS SINCE THAT TIME. THE PT CONFIRMED, HE WAS DISCONNECTED FROM THE INFUSION SITE EACH TIME HE PERFORMED AN EZPRIME TASK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR