BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3948880 · Received July 22, 2014

    Report

    Report Number
    2531779-2014-20865
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    July 12, 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

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND 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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/07/2014-PRODUCT ANALYSIS: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX SHOWED THE LAST BASAL DELIVERY WAS ON (B)(6) 2014, 2:11PM. THE TOTAL DAILY DOSE HISTORY CORRELATES APPROPRIATELY TO THE USER PROGRAMMED BASAL RATE. NO ABNORMAL ISSUES WERE OBSERVED IN THE PUMP¿S BLACK BOX. THE KEYPAD COVER WAS FOUND TO BE UNDAMAGED AND THE KEYPAD BUTTONS WERE APPROPRIATELY RESPONSIVE. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. NO INADVERTENT BASAL RATE CHANGES WERE OBSERVED. THE PUMP WAS FOUND TO BE DELIVERING ACCURATELY WITH A DELIVERY ACCURACY TEST.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THE PUMP¿S BASAL SETTINGS WERE INCORRECT. IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE WAS BETWEEN 250-499 MG/DL WITHOUT SYMPTOMS OF HYPERGLYCEMIA. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427766 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR