BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3885269 · Received June 19, 2014

    Report

    Report Number
    2531779-2014-17638
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    June 6, 2014
    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 FOR EVALUATION. 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

    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: REVIEW OF THE BLACK BOX DATA REVEALED NO ACTIVITY OUTSIDE OF NORMAL USE. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ANY ALARMS OR WARNINGS OCCURRING AND NO AIR BUBBLES DURING THE INVESTIGATION. INVESTIGATION DID NOT CONFIRM OR DUPLICATE THE COMPLAINT AND THE PUMP WAS FOUND TO BE PERFORMING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING BUBBLES INSIDE THE INSULIN CARTRIDGE NOT RESOLVED BY CARTRIDGE AND INFUSION SET CHANGE. THE HEALTH CARE PROVIDER VERIFIED THE PATIENT¿S FILLING TECHNIQUE AS PROPER. THE PATIENT¿S PUMP WAS REPLACED AND THE ISSUE WITH THE AIR BUBBLES ALLEGEDLY RESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360552 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1