BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4220619 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31215
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP 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. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/08/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED REBOOTING HAD OCCURRED ON (B)(6) 2014. THE RETURNED BATTERY CAP WAS USED TO COMPLETE INVESTIGATION. VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS INTACT WITH NO PHYSICAL DAMAGE. THE BATTERY CAP CONTACTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE BATTERY CAP WAS FASTENED AND UNSCREWED HALF A TURN WITH NO REBOOTS OCCURRING. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE AND A 24 HOUR EXERCISE TEST WITH NO POWER INTERRUPTIONS OR ALARMS OCCURRING. THE PUMP COVER WAS REMOVED AND THERE WERE NO DEFECTS FOUND TO THE POWER CIRCUIT. THE COMPLAINT COULD NOT BE DUPLICATED ON INVESTIGATION. 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) 2014 THE REPORTER CONTACTED ANIMAS ALLEGING AN INTERMITTENT POWER ISSUE WITH THE PUMP. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLE SHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703818 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1