BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 6048733 · Received October 21, 2016

    Report

    Report Number
    2531779-2016-29409
    Event Type
    Injury
    Date Received
    October 21, 2016
    Report Date
    October 6, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100051
    PMA / PMN Number
    P130007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/16/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/23/2016 WITH THE FOLLOWING FINDINGS: THE BLACK BOX BEGINS SHOWS THE PUMP WAS MANUALLY SUSPENDED ON (B)(6) 2016 16:36 AND MANUALLY RESUMED AT 17:22. THE LAST BOLUS DELIVERY WAS A 6.850U BOLUS ON (B)(6) 2016 13:05. PUMP WAS EXERCISED FOR 24HRS WITH A 2.0U/HR BASAL RATE; AT END TESTING THE BASAL HISTORY CORRECTLY SHOWED 2.0U AND TDD SHOWED 48.0U. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TESTING WITH NO DELIVERY DEFECTS FOUND. PUMP FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. NO DELIVERY INTERRUPTIONS OR EAW¿S OCCURRED DURING THE INVESTIGATION. UNABLE TO DUPLICATE THE COMPLAINT. 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)(4).

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT HAD A HYPOGLYCEMIC EVENT WHILE ON THE PUMP. THE REPORTER STATED THAT THE PATIENT'S BLOOD GLUCOSE WAS 36 MG/DL WITH DIFFICULTY SPEAKING, HEADACHE, AND CONFUSION. THE PATIENT RECEIVED TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT VIA IV GLUCOSE AND FLUIDS ADMINISTERED AT A HOSPITAL. IT WAS REPORTED THAT THE PATIENT WAS 7 WEEKS PREGNANT AND THAT THIS CONDITION COULD HAVE CONTRIBUTED TO THE INCIDENT. IT WAS REPORTED THAT THE BASAL HISTORY DID NOT MATCH THE ACTIVE BASAL PROGRAM BUT NO OTHER DETAILS WERE OBTAINED. THE PATIENT DISCONTINUED PUMP THERAPY. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY AND THE PUMP COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698252 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100051

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization