BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3011515 · Received March 19, 2013

    Report

    Report Number
    2531779-2013-02783
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 09/18/2013 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/23/2013 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX SHOWED EVIDENCE THAT POWER EVENTS HAD OCCURRED. THERE WAS NO PHYSICAL DAMAGE NOTED TO THE BATTERY COMPARTMENT OR CAP. THE BATTERY CAP SECURED TO THE PUMP AND THE PUMP POWERED ON APPROPRIATELY. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES. THE BATTERY CAP WAS TESTED AND WAS FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP COVER WAS REMOVED AND NO MOISTURE DAMAGE OR DEFECTS WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER STATED THAT THE PUMP HAD BEEN INTERMITTENTLY POWERING OFF FOR THE PAST FEW MONTHS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113853 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR