BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7166803 · Received January 4, 2018

    Report

    Report Number
    2531779-2018-00254
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Report Date
    December 10, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER CAREGIVERS

    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 23-FEB-2018 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12-FEB-2018 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX AND ALARM HISTORY SHOWED A CALL SERVICE 64 ALARM. DURING TESTING, THE PUMP SUCCESSFULLY COMPLETED THE REWIND, LOAD, AND PRIME STEPS WITHOUT ANY CALL SERVICE ALARMS OR ISSUES. THE PUMP SUCCESSFULLY COMPLETED THE 24 HOUR DURATION TEST WITHOUT ANY ISSUE OR CALL SERVICE ALARMS. THE PUMP COVER WAS REMOVED AND THERE WAS NO EVIDENCE OF MOISTURE OR DAMAGE TO THE INTERNAL COMPONENTS. THE ORIGINAL COMPLAINT OF A CALL SERVICE ALARM ISSUE WAS NOTED IN THE PUMP HISTORY BUT UNABLE TO BE DUPLICATED DURING INVESTIGATION. 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. .2-¿EZ-PRIME¿ STEPS WERE PERFORMED CORRECTLY, NO ¿CS064¿ ALARM OR ANY EAW OCCURRED DURING THE INVESTIGATION. UNABLE TO DUPLICATE ¿CS064¿ COMPLAINT. PUMP¿S COVER WAS REMOVED, NO INTERMITTENT CONDITION WAS FOUND TO THE PCB.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS AND REPORTED THAT CALL SERVICE ALARM [064] HAD BEEN EMITTED BY THE PUMP MORE OFTEN THAN EXPECTED BY THE USER. 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
    9871 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR