BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1952677 · Received January 4, 2011

    Report

    Report Number
    2531779-2011-00016
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 5, 2010
    Report Date
    December 5, 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
    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 THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED. THE LOSS OF DETECTION WAS DUPLICATED DURING TESTING. INVESTIGATION REVEALED A DISLODGED DISPLAY SCREEN AND FULLY DISLODGED FORCE SENSOR PINS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP DID NOT DETECT THE CARTRIDGE DURING THE EZPRIME FUNCTION. A FAMILY MEMBER STATED THAT HE ATTEMPTED TO COMPLETE THE EZPRIME STEPS THREE TIMES WITHOUT SUCCESS. HE REPORTED THAT THE REWIND STEP WAS VERY SLOW AND THERE WERE NO MOTOR NOISES.

    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 15 YR