BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2143431 · Received June 29, 2011

    Report

    Report Number
    2531779-2011-04554
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    April 24, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION #: 2531779-03/24/2010/003-R. (B)(6). THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION REVEALED A MISALIGNED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. AN EZPRIME OPERATION WAS PERFORMED AND DURING THE LOAD STEP THE PUMP DISPENSED THE FLUID FROM THE CARTRIDGE AND EMITTED A "NO CARTRIDGE DETECTED" WARNING. REVIEW OF THE PUMP HISTORY REVEALED TWO "NO CARTRIDGE DETECTED" WARNINGS AND LOSS OF PRIME WARNINGS ASSOCIATED WITH ZERO FORCE. UNRELATED TO THE COMPLAINT THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. ANIMAS HAS 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.

    Description of Event or Problem · 1

    THIS COMPLAINT IS A FOLLOW UP TO MFR REPORT # 2531779-2011-03769. A SUPPLEMENTAL REPORT COULD NOT BE SENT ON THAT REPORT. THE DISTRIBUTOR REPORTED THAT THE PUMP DISPENSED INSULIN FROM THE CARTRIDGE DURING AN EZPRIME OPERATION. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1