BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 5102814 · Received September 24, 2015

    Report

    Report Number
    2531779-2015-34365
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    September 4, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 11/05/2015 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/23/2015 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP WAS RETURNED WITH NO EVIDENCE OF MOISTURE IN THE PUMP. THE RETURNED BATTERY CAP SHOWED NO EVIDENCE OF PHYSICAL DAMAGE AND WAS ABLE TO SECURE PROPERLY TO THE PUMP. THE BATTERY COMPARTMENT THREADS WERE OBSERVED TO BE STRIPPED. A LEAK TEST WAS PERFORMED AND BATTERY COMPARTMENT LEAKS WERE FOUND. THE PUMP CASE WAS OPENED AND THERE WAS NO MOISTURE FOUND. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE AUDIO BOLUS BUTTON COVER WAS TORN, HOWEVER THE BUTTON RESPONDED APPROPRIATELY DURING TESTING. 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

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP W/MOISTURE) ISSUE. IT WAS REPORTED THAT THE BATTERY CAP WAS DAMAGED AND THERE WAS VISIBLE MOISTURE IN THE PUMP. 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
    633256 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1