BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4841664 · Received June 12, 2015

    Report

    Report Number
    2531779-2015-19649
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    May 29, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/17/2015-DEVICE EVALUATION:THE BATTERY CAP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/29/2015 WITH THE FOLLOWING FINDINGS: DURING INSPECTION OF THE BATTERY CAP, THE SLOT ON THE TOP OF THE CAP WAS OBSERVED TO BE WORN.

    Additional Manufacturer Narrative · 1

    THE BATTERY CAP HAS NOT BEEN RETURNED TO ANIMAS. 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

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (EXTERNAL COMPONENT ISSUE) ISSUE. IT WAS REPORTED THAT THE TOP OF THE PUMP BATTERY CAP WAS WORN. 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
    385025 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR