BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3253719 · Received July 30, 2013

    Report

    Report Number
    2531779-2013-12076
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 8, 2013
    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 09/10/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 08/21/2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. UNABLE TO DUPLICATE "BLANK" DISPLAY SCREEN. TESTING CONFIRMED THE DISPLAY SCREEN IS FULLY FUNCTIONAL AND IS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF DAMAGE, FADING OR DISCOLORATION. BLACK BOX/ALARM HISTORY SHOWS NO INDICATION OF MALFUNCTION RELATED TO COMPLAINT. 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

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013 AND REPORTED THE DISPLAY SCREEN WAS BLANK. 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
    356362 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1