BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7750468 · Received August 5, 2018

    Report

    Report Number
    2531779-2018-14225
    Event Type
    Malfunction
    Date Received
    August 5, 2018
    Report Date
    July 18, 2018
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 13-SEP-2018 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THERE WAS A CALL SERVICE 078-0008 ALARMS IN PUMP HISTORY. DURING REWIND, THE PUMP GAVE A CALL SERVICE 078-0008 ALARM. UNABLE TO PERFORM STEPS 21 AND 35 DUE TO ALARM. THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS FOUND ON THE PRINTED CIRCUIT BOARD. ALARM DUE TO MOISTURE DAMAGE.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 078) 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
    591961 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR