BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6188715 · Received December 20, 2016

    Report

    Report Number
    2531779-2016-33952
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Report Date
    November 25, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 02/10/2017. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/21/2017 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. 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

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE CUSTOMER ALLEGED THAT THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION HAS THE ABILITY TO RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR THE CARTRIDGE COMPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840792 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR