BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 5484377 · Received March 7, 2016

    Report

    Report Number
    2531779-2016-05344
    Event Type
    Malfunction
    Date Received
    March 7, 2016
    Report Date
    February 17, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 04/14/2216. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/22/2016 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON WITH VISIBLE MOISTURE BEHIND THE DISPLAY LENS AND AN UNRESPONSIVE KEYPAD. ADDITIONAL TESTING FOR THE ALLEGED POWER ISSUE COULD NOT BE COMPLETED DUE TO THE UNRESPONSIVE KEYPAD BUTTONS. INVESTIGATION REVEALED A CRACK IN THE PUMP CASING NEAR THE UPPER RIGHT CORNER OF THE DISPLAY LENS AND CRACKS IN THE BATTERY COMPARTMENT. LEAK TESTING REVEALED LEAKS AT THE BATTERY COMPARTMENT AND THE PUMP CASE. THE PUMP WAS OPENED AND THERE WAS EVIDENCE OF MOISTURE OBSERVED ON MULTIPLE INTERNAL PUMP COMPONENTS. MOISTURE ON THE INTERNAL COMPONENTS WAS DETERMINED TO BE THE REASON FOR THE UNRESPONSIVE KEYPAD BUTTONS.

    Description of Event or Problem · 1

    ON 02/17/2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. REPORTEDLY, THE BATTERY COMPARTMENT WAS DAMAGED AND THE PUMP HAD AN INTERMITTENT POWER ISSUE. THE REPORTER NOTED THAT THE BATTERY CAP WAS ORIGINAL TO THE PUMP FROM (B)(6) 2014. 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
    139713 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR