BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 6128542 · Received November 28, 2016

    Report

    Report Number
    2531779-2016-32237
    Event Type
    Injury
    Date Received
    November 28, 2016
    Report Date
    October 29, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100211
    PMA / PMN Number
    P130007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    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 CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 02/22/2017. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/02/2017 WITH THE FOLLOWING FINDINGS: REVIEW OF THE PUMP DOWNLOAD SHOWED THE LAST BASAL DELIVERY AND THE LAST BOLUS DELIVERY WERE ON (B)(6) 2017. THE PUMP HISTORY SHOWED THE FOLLOWING MANUAL SUSPENDS AND MANUAL RESUMES ON (B)(6) 2016: AT 06:18 MANUAL SUSPEND AND MANUAL RESUME AT 06:19. AT 06:17 MANUAL SUSPEND AND MANUAL RESUME AT 06:18. AT 05:32 MANUAL SUSPEND AND MANUAL RESUME AT 06:17. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. THE TOTAL DAILY DOSES ADDED UP CORRECTLY TO REFLECT THE USER¿S PROGRAMMED BASAL RATES. NO ERRORS, ALARMS, WARNINGS OR DELIVERY INTERRUPTIONS OCCURRED DURING THE TESTING. INVESTIGATION DID NOT DUPLICATE THE COMPLAINT.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT WAS CONFUSED WHEN WAKENING AND THOUGHT THE PUMP WAS SUSPENDED; CHECKED ALARMS AND SUSPEND HISTORY, AND THEN SELF TREATED FOR A BLOOD SUGAR OF 60MG/DL. CUSTOMER SUPPORT ATTRIBUTED THE BG EXCURSION TO TRAINING/MISUSE. PATIENT RECEIVED NO TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT AND REMAINS ON PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780114 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100211

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening