BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6766168 · Received August 3, 2017

    Report

    Report Number
    2531779-2017-17269
    Event Type
    Malfunction
    Date Received
    August 3, 2017
    Report Date
    July 10, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100068
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF SUBMISSION (B)(4) 2017 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)94) 2017 WITH THE FOLLOWING FINDINGS: THE BLACK BOX AND ALARM HISTORY SHOWED MULTIPLE CALL SERVICE ¿(B)(4)¿ ALARMS. THE EZ-PRIME SEQUENCE WAS COMPLETED WITH NO ERRORS, ALARMS OR WARNINGS DURING THE INVESTIGATION. THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED AND THE RETURNED BATTERY CAP WAS UNDAMAGED AND FIT SECURELY. THE PUMP¿S COVER WAS REMOVED AND NO INTERMITTENT CONDITION WAS FOUND. 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

    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) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (COMMUNICATION) 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
    543496 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100068

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR