BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2230457 · Received September 1, 2011

    Report

    Report Number
    2531779-2011-06412
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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: MOISTURE WAS OBSERVED BEHIND THE PUMP DISPLAY LENS. A LEAK TEST WAS PERFORMED AND THE DISPLAY LENS WAS FOUND TO BE LEAKING. THE PUMP WAS UNABLE TO POWER ON. THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS OBSERVED INSIDE THE PUMP.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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. (B)(6).

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT THE PATIENT RECEIVED AN OCCLUSION ALARM APPROXIMATELY 2 HOURS PRIOR, THEY DECIDED TO CHANGE THE BATTERY AND NOW THE PUMP HAS NO POWER.

    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 12 YR