BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6351861 · Received February 22, 2017

    Report

    Report Number
    2531779-2017-04137
    Event Type
    Malfunction
    Date Received
    February 22, 2017
    Report Date
    February 1, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100051
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 04/13/2017. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/23/2017 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE RETURNED BATTERY CAP AND TEST CAP WERE ABLE TO ATTACH SECURELY TO THE PUMP. ALL THE BATTERY CAP CONTACTS WERE WITHIN SPECIFICATION. THERE WERE TWO UNEXPLAINED PUMP REBOOTS OBSERVED IN THE BLACK BOX. THERE WAS NO EVIDENCE OF MOISTURE OBSERVED BEFORE THE PUMP WAS OPENED. A LEAK TEST PASSED WITH NO LEAKS DETECTED. THE PUMP WAS OPENED AND THERE WAS NO DAMAGE OBSERVED TO THE POWER CIRCUIT. THERE WAS NO MOISTURE OBSERVED INTERNALLY. THE PUMP WAS SUCCESSFULLY RUN ON A 24 HOURS BASAL PROGRAM WITH NO REBOOTS OCCURRING. THE ORIGINAL COMPLAINT WAS UNABLE TO BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE 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) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. IT WAS ALLEGED THAT THERE WAS MOISTURE IN THE BATTERY COMPARTMENT AND THERE WAS INTERMITTENT POWER. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131111 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100051

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR