BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3223478 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10501
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 12/23/2013.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 PUMP WAS RETURNED FOR INVESTIGATION WITH THE INSULIN-ON-BOARD DURATION SET FOR 4.0 HOURS. THE PUMP WAS EXERCISED FOR 48 HOURS WITHOUT ISSUE. THE INSULIN-ON-BOARD FUNCTION WAS TESTED AND WAS FOUND TO BE OPERATING TO WITHIN SPECIFICATIONS FOR THIS MODEL INSULIN PUMP. THE INSULIN-ON-BOARD FEATURE OF THIS PUMP WAS DETERMINED TO BE OPERATING AS DESIGNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTOR ALLEGED THAT THE INSULIN-ON-BOARD FEATURE OF THE PUMP IS SET FOR FOUR HOURS; HOWEVER, AFTER FOUR HOURS¿ TIME THERE IS STILL A VALUE OF INSULIN-ON-BOARD WITHOUT THE USER HAVING ADMINISTERED ANY ADDITIONAL BOLUSES DURING THE INSULIN-ON-BOARD TIME. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE WITH THE INSULIN-ON-BOARD WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323671 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1