BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7246705 · Received February 6, 2018

    Report

    Report Number
    2531779-2018-02863
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Report Date
    January 25, 2018
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12-FEB-2018 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOED EVIDENCE OF CALL SERVICE 052/084/012 ALARMS ON THE DATE OF THE COMPLAINT. THE PUMP POWERED UP WITH THE RETURNED BATTERY CAP TO A BLANK DISPLAY WITH AUDITORY AND VIBRATORY ALARMS. THE PUMP CASE WAS REMOVED TO FIND NO MOISTURE. A SLAVE PROCESSOR FAILURE WAS CONCLUDED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN AN INABILITY TO USE THE PRODUCT WHICH MAY LEAD TO LONG TERM CESSATION OF DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90058 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR