BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6137290 · Received November 30, 2016

    Report

    Report Number
    2531779-2016-32574
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Report Date
    November 4, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    MDS
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 01/11/2017. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/16/2016 WITH THE FOLLOWING FINDINGS: TESTING REVEALED THAT AUDIBLE TONES FUNCTIONED INTERMITTENTLY AT PIEZO ACTIVATION. ALL AUDIBLE TONES WERE SET TO ¿HIGH¿ WITH THE EXCEPTION OF THE TEMPORARY BASAL ALERT. THE PUMP CASE WAS REMOVED, AND A PIEZO CONTACT ALIGNMENT FAILURE WAS FOUND. THE COMPLAINT WAS DUPLICATED.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (NO SOUNDS) ISSUE. NO FURTHER INFORMATION WAS AVAILABLE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY CAUSE THE USER TO MISS AN ALARM OR WARNING THAT MAY CAUSE CESSATION OF INSULIN DELIVERY. 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
    787882 ANIMAS VIBE INSULIN INFUSION PUMP MDS ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1