BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4182822 · Received October 17, 2014

    Report

    Report Number
    2531779-2014-29620
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    October 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/18/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT OF LINE THROUGH DISPLAY COULD NOT BE DUPLICATED. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY WAS FOUND TO BE DIM AND PINK. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED BELOW THE BUMPER PAD; THE BATTERY CAP WAS MISSING; A TEST CAP WAS USED FOR ALL STEPS AND WAS ABLE TO BE FULLY TIGHTENED. 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.

    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).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A DISPLAY ISSUE. THE REPORTER STATED THAT THERE WERE LINES THROUGH THE DISPLAY. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661614 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1