BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4110353 · Received September 23, 2014

    Report

    Report Number
    2531779-2014-27118
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/20/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE LAST BASAL DELIVERY WAS ON (B)(6) 2013 AT 2:52PM. THE BLACK BOX REVEALED AN UNACKNOWLEDGED CALL SERVICE (CS) 162 WARNING FOR 5 HOURS ON (B)(6) 2013 AT 6:02PM FOLLOWED BY A POWER INTERRUPTION FOR 38 HOURS. DELIVERY WAS RESUMED ON (B)(6) 2013 AT 1:37PM. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WERE NO ERRORS, ALARMS OR WARNINGS THAT OCCURRED DURING THE INVESTIGATION. THE PUMP WAS ON A 24 HOUR DURATION TEST SET TO 1 UNIT/HOUR DELIVERY RATE. THE PUMP DELIVERED THE PUMP DISPLAYED THE CORRECT AMOUNT OF UNITS WHICH WAS A TOTAL OF 24 UNITS DELIVERED. THE PUMP WAS FOUND TO MEET SPECIFICATION AND THE REPORTED ALLEGATION OF A HISTORY/SETTINGS ISSUE INVOLVING THE BASAL DELIVERY WAS NOT DUPLICATED DURING INVESTIGATION. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED FROM THE BUMPER GRIP DOWN TO THE CASES SEAL. ALSO UNRELATED TO THE COMPLAINT, THE TEXT ON THE DISPLAY SCREEN WAS FOUND TO BE DIM AND REDDISH.

    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).

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING A HISTORY/SETTINGS ISSUE INVOLVING THE BASAL DELIVERY. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED HISTORY/SETTINGS ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592258 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1