BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4812216 · Received June 2, 2015

    Report

    Report Number
    2531779-2015-18051
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Report Date
    May 15, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 7/9/15. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/22/2015 WITH THE FOLLOWING FINDINGS: TESTING CONFIMRED THE RETURNED CAP WAS UNABLE TO TIGHTEN TO TEST INTO THE RETURNED PUMP'S BATTERY COMPARTMENT DUE TO TORN CAP SLOT AND STRIPPED THREADS. CAP CONTACT HEIGHT AND WIDTH FOUND TO BE ABOVE SPECIFICATION. TEST CAP USED INSTEAD OF DAMAGED RETURN CAP DURING INVESTIGATION. PUMP IS NORMALLY OPERATIVE THERE IS NO CRACKED/DAMAGED AROUND PUMP CASES OR OTHER AREA OF THE PUMP.

    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).

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE) ISSUE. AFTER A BATTERY CHANGE, BATTERY CAP CAN NOT BE REMOVED. THE CAP IS FULLY SEATED BUT ROTATES BOTH WAYS WITHOUT RESISTANCE AND MULTIPLE ATTEMPTS TO REMOVE IT WERE UNSUCCESSFUL. 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
    357118 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1