BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6076906 · Received November 3, 2016

    Report

    Report Number
    2531779-2016-30517
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Report Date
    October 13, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 1/27/2017 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 1/09/2017 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP WAS POWERED ON AND EMITTED A CS 069 CALL SERVICE ALARM IMMEDIATELY. THE CALL SERVICE ALARM WAS RECORDED IN THE BLACK BOX DATA AS A CS 087 FAILURE, INDICATING A LANGUAGE FILE CORRUPTION DUE TO A FAILED U39 COMPONENT ON THE PRINTED CIRCUIT BOARD. 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 PUMP 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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED A CS 069 CALL SERVICE ALARM. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729014 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1