BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4132880 · Received October 1, 2014

    Report

    Report Number
    2531779-2014-28025
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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)(6).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/19/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED. THE RETURNED BATTERY CAP WAS USED TO COMPLETE INVESTIGATION. THE PUMP WAS UNABLE TO POWER ON AND WAS COMPLETELY UNRESPONSIVE. THE COMPLAINT OF A PRIME ISSUE COULD NOT BE ADEQUATELY INVESTIGATED DUE TO INABILITY TO POWER ON THE PUMP. THE PUMP COVER WAS REMOVED AND THERE WAS EVIDENCE OF MOISTURE CORROSION ON THE PCB. 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 THAT THE PUMP WAS EMITTING ¿NO PRIME¿ ALARMS, AND THAT THE CARTRIDGE WAS EMPTIED DURING THE PRIME STEP. NO ADDITIONAL INFORMATION WAS PROVIDED. 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 TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612312 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1