BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6053899 · Received October 25, 2016

    Report

    Report Number
    2531779-2016-29610
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    October 14, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100051
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 12/27/2016 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY SHOWED MULTIPLE CALL SERVICE 087 ALARMS. THE ISSUE WAS DUPLICATED DURING POWER UP. THE CALL SERVICE 069 FAILURE WAS WRITTEN TO THE BLACK BOX AS A CALL SERVICE 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 COMPARTMENT WAS CRACKED BELOW THE GRIP PAD.

    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 THERE WAS A 069 CALL SERVICE ALARM. THERE WAS NO INDICATION THAT THIS ISSUE LEAD TO AN ADVERSE EVENT. THIS 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
    704180 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100051

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR