BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6093473 · Received November 10, 2016

    Report

    Report Number
    2531779-2016-31162
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Report Date
    October 18, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    MDS
    UDI-DI
    10840406100242
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/29/2017 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED THE DATA FROM THE DATE OF THE COMPLAINT HAD BEEN OVERWRITTEN. THE CURRENT BLACK BOX SHOWED EVIDENCE OF AN UNEXPLAINED POWER ON RESET EVENT. THE PUMP INTERMITTENTLY POWERED ON WITH THE RETURNED BATTERY CAP . THE BATTERY CAP THREADS WERE DAMAGED AND THE BATTERY CAP MEASURED WITHIN SPECIFICATIONS. A TEST BATTERY CAP WAS USED FOR ALL TESTING. THE BATTERY COMPARTMENT WAS CRACKED FROM THE THREAD AREA TO THE CASE SEAL. THE BATTERY COMPARTMENT THREADS WERE DAMAGED. EVIDENCE OF MOISTURE WAS FOUND INSIDE THE BATTERY COMPARTMENT, AND ON THE UNDERSIDE OF THE BATTERY CAP. THE REWIND, LOAD, AND PRIME STEPS WERE PERFORMED SUCCESSFULLY. THE PUMP WAS RUN FOR 24 HOURS AND NO REBOOTS, LOSS OF POWERS OR CALL SERVICE ALARMS WERE DUPLICATED. THE PUMP CASE WAS REMOVED TO FIND NO EVIDENCE OF ADDITIONAL MOISTURE. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PUMP HAD AN INTERMITTENT POWER ISSUE. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THIS COMPLAINT 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
    743960 ANIMAS VIBE INSULIN INFUSION PUMP MDS ANIMAS CORPORATION 10840406100242

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR