BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 5899143 · Received August 23, 2016

    Report

    Report Number
    2531779-2016-22660
    Event Type
    Malfunction
    Date Received
    August 23, 2016
    Report Date
    August 2, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. (B)(64).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 10/28/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/03/2016 WITH THE FOLLOWING FINDINGS: THE BLACK BOX AND ALARM HISTORY SHOWED EVIDENCE OF THE CS 078 CALL SERVICE ALARM . THE PUMP¿S ¿EZ-PRIME¿ STEPS WERE PERFORMED CORRECTLY. THE PUMP¿S COVER WAS REMOVED AND THERE WAS MOISTURE CORROSION FOUND TO THE MOTOR CONNECTOR. DURING THE INVESTIGATION, THE PUMP ALARMED WITH ¿CS 078¿ ALARM UPON THE FIRST REWIND ATTEMPT THEREFORE THE INITIAL CALL SERVICE ALARM COMPLAINT WAS DUPLICATED DURING THE INVESTIGATION. UNRELATED TO THE INITIAL COMPLAINT, IT WAS OBSERVED THAT THE BATTERY COMPARTMENT HAD TWO CRACKS AND THE DISPLAY SCREEN WAS DIM AND DISCOLORED. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2, 21-MARCH-2017- CORRECTION TO SERIAL#.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM 078-0080134 ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED 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
    550604 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1