BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3063675 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04423
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. NO ACTIVITY OUTSIDE OF NORMAL USE IN OBSERVED IN THE BLACK BOX, HISTORY REVIEW SHOWS IOB SETTINGS TO ¿ON¿/1.5H. PUMP POWERS UP AND DISPLAYS¿VERIFY¿ SCREEN. PUMP WAS PRIMED. FORCE SENSOR CALIBRATION READING IS WITHIN SPECIFICATION.. NO ALARMS OCCURRED DURING TESTING. PUMP WAS OPENED; NO MOISTURE CORROSION OR INTERMITTENT CONDITION WAS FOUND TO THE PCB. A 1.5U/1H COMBO BOLUS WITH 40% EXTENSION WAS PERFORMED ON (B)(4) 2013 AT 11:25AM, PUMP DELIVERED RIGHT AWAY THE APPROPRIATE AMOUNT. STATUE IOB SCREEN N2 SHOWED 0.6U.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTOR CONTACTED ANIMAS AND ALLEGED THAT THE CUSTOMER IS CONCERNED ABOUT INSULIN DELIVERY AND THE IOB ON HIS NEW VIBE PUMP. TODAY HE DID AN EXTENDED BOLUS FOR 1 HOUR OF 1.5 UNITS, WITH 40% (0.6 UNITS) DELIVERED STRAIGHT AWAY, THEN CHECKED HIS IOB IMMEDIATELY AFTERWARDS AND IT SHOWED 0.4 UNITS. HIS IOB DURATION IS 2.5 HOURS. HE SAID IT ALWAYS SHOWS APPROXIMATELY 80% ON HIS IOB THAT HE HAS JUST DELIVERED. AFTER REBOOTING THE PUMP, THE IOB RETURNED TO NORMAL BUT HE DOES NOT TRUST THE PUMP ANY LONGER. THERE IS NO ALLEGATION OF AN ADVERSE EVENT RELATED TO THIS ISSUE. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP IS NOT ACCURATELY DELIVERING INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166482 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1