BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3791478 · Received May 5, 2014

    Report

    Report Number
    2531779-2014-12529
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/30/2014 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA REVEALED AN ¿OUT OF THE BOX PUMP¿ THAT WAS NEVER USED FOR BASAL DELIVERY WITH CONSECUTIVE POWER ON RESET EVENT RECORDED ON (B)(6) 2014. THE BATTERY VOLTAGES PRIOR TO THE POWER ON RESET EVENTS WERE ABOVE THE BATTERY ALARM/WARNING THRESHOLD. ON VISUAL INSPECTION, THE BATTERY COMPARTMENT WAS INTACT WITHOUT DAMAGE. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. A TEST CAP WAS USED FOR TESTING AND ATTACHED TO THE PUMP PROPERLY AND MAINTAINED ELECTRICAL CONNECTION. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT INTERRUPTION OF POWER. THE PUMP WAS OPENED FOR INVESTIGATION AND DID NOT REVEAL ANY EVIDENCE OF DAMAGE, DEFECT OR CONTAMINATION OF THE PUMP¿S INTERIOR COMPONENTS, INCLUDING THE POWER CIRCUIT. INVESTIGATION DID NOT DUPLICATE THE REPORTED INTERMITTENT POWER ISSUE AND THE PUMP WAS FOUND TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(6). 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.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING THE PUMP HAD AN INTERMITTENT POWER ISSUE. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266425 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1