BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3760460 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10648
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    April 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWS 0.56U DELIVERED OUT OF 0.75U PROGRAMMED BOLUS ON (B)(6) 2014@1:06AM. PUMPS USER SETTINGS SHOW THE ¿IOB DURATION¿ WAS SET 4.0 HOURS. A TEST WAS PERFORMED WITH 10 UNIT BOLUS AND A DURATION PERIOD OF 2.0 HOURS. AFTER THE 2 HOURS THE IOB REFLECTED IN THE STATUS SCREEN N2 WAS 0.00. THE IOB WAS FOUND TO BE FUNCTIONING PROPERLY. A 0.75U BOLUS WAS PERFORMED AND IT WAS REFLECTED IN THE IOB STATUS SCREEN N2, UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION. THE PRODUCT PERFORMS WITHIN SPECIFICATIONS. ANOMALY IS OBSERVED IN THE BLACK BOX, THE IOB DURATION FEATURE IS OPERATING AS DESIGNED. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 REPORTING THAT THE INSULIN ON BOARD (IOB) IS NOT CALCULATING CORRECTLY INTO BOLUS TOTAL. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE HISTORY SETTINGS (IOB) ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240377 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR