BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2101595 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03664
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE PRODUCT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011. A REVIEW OF PUMP HISTORY REVEALED SEVERAL LOSS OF PRIMES DUE TO LOW NON ZERO FORCE. EVALUATION REVEALED A CROOKED LED DISPLAY. IT WAS OBSERVED THAT THE FORCE SENSOR FLEX PINS WERE PARTIALLY DISLODGED FROM THE PCB SOCKETS. CORRECTION NUMBER: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PATIENT RETURNED PUMP FOR MULTIPLE LOSS OF PRIMES. EVALUATION REVEALED THAT THE FORCE SENSOR FLEX PINS ARE PARTIALLY DISLODGED FROM THE PCB SOCKETS. THIS REPORT IS MADE BASED ON THE EVALUATION RESULTS.

    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 39