BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3790151 · Received May 5, 2014

    Report

    Report Number
    2531779-2014-12464
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    May 4, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT THE LAST BASAL DELIVERY OCCURRED ON (B)(6) 2014. THE PUMP BLACK BOX INDICATED THAT THE PUMP EMITTED A LOSS OF PRIME WARNING AT 16:07 ON (B)(6) 2014; THE PUMP ALARM WAS CONFIRMED AT 16:10 AND THE PUMP WAS PRIMED AND DELIVERY RESUMED AT 16:17. THE PUMP BLACK BOX SHOWED ONE UNEXPLAINED POWER ON EVENT OCCURRING AT 20:43 ON (B)(6) 2014; THE PUMP VOLTAGE RECORDED AT THE TIME OF THE EVENT WAS WITHIN NORMAL RANGE. THE PUMP WAS NEXT POWERED ON (B)(6) 2014 BUT THE INSULIN DELIVERY WAS NOT RESUMED. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    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

    THIS SUPPLEMENTAL IS TO CORRECT THE BRAND NAME OF THE PRODUCT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PUMP MAY NOT HAVE BEEN DELIVERING APPROPRIATELY. THE PUMP WAS REVIEWED AND FOUND THAT BASAL HISTORY MATCHED THE ACTIVE BASAL PROGRAM, THE BOLUS TOTALS MATCHED AND ALL OF THE BOLUSES WERE RECORDED AS PROGRAMMED. DURING TESTING, THE PUMP WAS ABLE TO SUCCESSFULLY DELIVER A 1 UNIT BOLUS WHICH WAS CORRECTLY RECORDED IN THE PUMP HISTORY. THIS COMPLAINT IS BEING REPORTED BASED ON ALLEGED DELIVERY ISSUE WHICH WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267529 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR