BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 5654412 · Received May 13, 2016

    Report

    Report Number
    2531779-2016-09967
    Event Type
    Malfunction
    Date Received
    May 13, 2016
    Report Date
    April 27, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    MDS
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/06/2016 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA REVEALED RECORD OF A LOSS OF PRIME EVENT ON (B)(6) 2016 23:48; DELIVERIES WERE NEVER RESUMED. THE LAST BOLUS DELIVERY WAS A 0.40 UNIT BOLUS ON (B)(6) 2016 AT 23:05. THE TOTAL DAILY DOSES ADDED UP TO CORRECTLY REFLECT THE USER¿S PROGRAMMED BASAL RATES. DURING INVESTIGATION, THE PUMP PASSED DELIVERY ACCURACY TESTING WITH NO DELIVERY DEFECTS FOUND. THE PUMP WAS DETERMINED TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY WITH NO DELIVERY INTERRUPTIONS, ERRORS, ALARMS OR WARNINGS OCCURRING DURING TESTING. INVESTIGATION DID NOT DUPLICATE THE COMPLAINT AND THE PUMP WAS FOUND TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (INACCURATE DELIVERY) ISSUE; SPECIFIC DETAILS OF THE ALLEGED ISSUE WERE NOT PROVIDED. THIS COMPLAINT IS BEING REPORTED BECAUSE THERE IS AN ALLEGATION AGAINST THEDELIVERY FUNCTION OF THE PUMP. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309042 ANIMAS VIBE INSULIN INFUSION PUMP MDS ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1