BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2133037 · Received June 17, 2011

    Report

    Report Number
    2531779-2011-04259
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    February 18, 2011
    Report Date
    May 17, 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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS ON NORMALLY. A REVIEW OF THE PUMP HISTORY INDICATED THAT REBOOTING HAD OCCURRED, WHICH COULD NOT BE DUPLICATED DURING TESTING. THERE WERE NO ALARMS RELATED TO THE COMPLAINT NOTED IN THE PUMP HISTORY. THERE WAS NO DAMAGE FOUND TO THE BATTERY CAP, BATTERY COMPARTMENT, AND POWER CIRCUIT. THE BATTERY CAP WAS ABLE TO ATTACH SECURELY TO THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OR ALARMS OCCURRING.

    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.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. IT WAS REPORTED THAT THE PUMP LOST PRIME MULTIPLE TIMES. CUSTOMER SUPPORT DETERMINED THAT THERE WAS EVIDENCE THAT THE LOSS OF PRIME MAY HAVE BEEN THE RESULT OF THE PUMP REBOOTING WITHOUT USER INTERVENTION. THE COMPLAINT IS BEING REPORTED BECAUSE POWER LOSS CAN RESULT IN UNDER DELIVERY OF INSULIN.

    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