BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6108306 · Received November 16, 2016

    Report

    Report Number
    2531779-2016-31487
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Report Date
    October 23, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    MDS
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/03/2017 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND ALARM HISTORY SHOWED ¿CS012¿ SLAVE COMMUNICATION ERROR ALARMS ON (B)(6) 2016. NO ¿CS012¿ ALARM OR ANY EAW OCCURRED DURING THE INVESTIGATION, THE PRODUCT PERFORMED WITHIN SPECIFICATIONS AND INVESTIGATION DID NOT DUPLICATE THE ¿CS012¿ COMPLAINT. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS NOTED TO BE CRACKED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 012) ISSUE; 12-00A30042. 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. 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
    759155 ANIMAS VIBE INSULIN INFUSION PUMP MDS ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR