BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7640326 · Received June 26, 2018

    Report

    Report Number
    2531779-2018-11748
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Report Date
    June 19, 2018
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02 -AUG-2018 WITH THE FOLLOWING FINDINGS: DURING INSTIGATION, THERE WAS A CALL SERVICE 064-0008 AND 078-0008 ALARMS IN PUMP HISTORY ON DATE OF REPORTED ALARM. DURING REWIND, THE PUMP GIVES A CALL SERVICE 078-0008 ALARM. UNABLE TO PERFORM STEPS 21 AND 22 DUE TO ALARM. PUMP OPENED AND MOISTURE DAMAGE FOUND ON THE PRINTED CIRCUIT BOARD. THE ALARM OCCURRED DUE TO MOISTURE DAMAGE.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. 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
    479490 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR