BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2980732 · Received February 27, 2013

    Report

    Report Number
    2531779-2013-02201
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED LOSS OF PRIME WITH ZERO FORCE IN THE BLACK BOX HISTORY. THE REWIND, PRIME AND LOAD STEPS WERE PERFORMED ON THE PUMP WITH NO LOSS OF PRIME ISSUES WITH LOSS OF PRIME. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL PROGRAM WITH NO LOSS OF PRIME. INVESTIGATION REVEALED THAT THE FORCE SENSOR FLEX PINS WERE FOUND TO BE PARTIALLY DISLODGED FROM THE PRINTED CIRCUIT BOARD (PBB). 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.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE FORCE SENSOR FLEX PINS WERE FOUND TO BE PARTIALLY DISLODGED FROM THE PRINTED CIRCUIT BOARD (PBB). THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84886 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR