BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 4821352 · Received June 5, 2015

    Report

    Report Number
    2531779-2015-18723
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 4, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT 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 ORIGINALLY SUBMITTED ON (B)(6) 2015, RESUBMITTED PER ESG REQUEST ON (B)(6) 2015. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. THE PUMP HISTORY SHOWED THAT ON (B)(6) 2015, THE PUMP WAS MANUALLY SUSPENDED AT 07:34 AND MANUALLY RESUMED AT 08:32. A DELIVERY ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS INDICATING THAT THE PATIENT REQUIRED PHONE ADVICE FROM A HEALTH CARE PROFESSIONAL FOR AN ALLEGED A BLOOD GLUCOSE OF 26 MMOL/L WITH VOMITING, DROWSINESS / DIFFICULTY WAKING UP, INCREASED THIRST, AND LARGE KETONES RELATED TO INACCURATE DELIVERY. THE PUMP WAS REVIEWED WITH THE REPORTER WHO INDICATED THAT THE BASAL AND BOLUS AMOUNTS DID NOT MATCH WITH THE TOTAL DAILY DOSE HISTORY. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA REQUIRING ADVICE FROM A HEALTH PROFESSIONAL RELATED TO AN INACCURATE DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365012 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening