BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 5983064 · Received September 28, 2016

    Report

    Report Number
    2531779-2016-27034
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Report Date
    September 6, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    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

    FOLLOW-UP #1: DATE OF SUBMISSION 11/09/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/20/2016 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP WAS POWERED ON AND EMITTED A CS 069 CALL SERVICE ALARM IMMEDIATELY UPON ATTEMPTING A REWIND STEP. THE CALL SERVICE ALARM WAS RECORDED IN THE BLACK BOX DATA AS A CS 087 FAILURE. INVESTIGATION REVEALED THAT A LANGUAGE CORRUPTION OCCURRED AT A COMPONENT ON THE PRINTED CIRCUIT BOARD RESULTING IN A CALL SERVICE ALARM. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY CAP WAS RETURNED STUCK TO THE PUMP AND HAD TO BE FORCIBLY REMOVED. THE BATTERY CAP COIN SLOT WAS FOUND TO BE DAMAGED. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. 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).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT 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
    636156 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR