BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2133833 · Received June 20, 2011

    Report

    Report Number
    2531779-2011-04278
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Report Date
    May 24, 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

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE DOWN ARROW BUTTON WAS FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER ALL BUTTON CONTACTS AND THE DOWN ARROW BUTTON CONTACT WAS MISALIGNED. 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

    A FAMILY MEMBER REPORTED THAT THE PUMP DOWN ARROW SEEMS TO BE SEATED OFF TO THE SIDE AND REQUIRED WORKING THE BUTTON TO GET A RESPONSE. THE PATIENT REPORTEDLY WORE THE PUMP IN A POUCH AROUND WAIST AND DID NOT CLEAN THE PUMP.

    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 13 YR