BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4143559 · Received October 6, 2014

    Report

    Report Number
    2531779-2014-28379
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    September 25, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2014. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED ONE REBOOT ASSOCIATED WITH A BATTERY CHANGE ON (B)(4) 2014. THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE PUMP HISTORIES. VISUAL INSPECTION FOUND NO DAMAGE TO THE BATTERY CAP AND BATTERY COMPARTMENT, AND THE BATTERY CAP WAS ABLE TO SECURE PROPERLY TO THE PUMP AND MAINTAINED AN ELECTRICAL CONNECTION. THE PUMP POWERED ON NORMALLY TO THE VERIFY SCREEN WITH NO ISSUES. A REWIND, LOAD, AND PRIME SEQUENCE WAS PERFORMED WITH NO ISSUES OCCURRING, AND THE PUMP SUCCESSFULLY COMPLETED A 24 HOUR EXERCISE TEST WITH NO ISSUES. THE ACTIVE BASAL PROGRAM WAS SET TO 1 UNIT PER HOUR, AND THE PUMP WAS TURNED OFF FOR ONE HOUR. WHEN THE PUMP WAS POWERED BACK ON, INVESTIGATION FOUND THAT THE ACTIVE BASAL PROGRAM REMAINED IN THE PUMP AS PROGRAMMED. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION.

    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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS ISSUE WITH THE BASAL PROGRAMMING. THE PUMP SCREEN WENT BLANK AND WAS MAKING A CONTINUAL HIGH PITCH SOUND. AFTER TRYING DIFFERENT ENERGIZER ULTIMATE LITHIUM BATTERIES, THE PUMP TURNED BACK ON AFTER AROUND 1 HOUR, BUT ALL BASAL RATES HAD RETURNED TO DEFAULT VALUES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. 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
    623032 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1