BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7291442 · Received February 22, 2018

    Report

    Report Number
    2531779-2018-04093
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Report Date
    February 13, 2018
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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: 06-APR-2018. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 28-MAR-2018 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE BLACK BOX AND ALARM HISTORY SHOW NO EVIDENCE OF ¿CS120-0830042¿ ALARM. RETURNED BATTERY CAP IS UNDAMAGED AND ABLE TO FIT THE EZ-PRIME¿ STEPS WERE PERFORMED CORRECTLY, NO ALARMS OCCURRED DURING THE INVESTIGATION, UNABLE TO DUPLICATE ¿CS120-0830042¿ COMPLAINT. PUMP¿S COVER WAS REMOVED, NO MOISTURE CORROSION OR INTERMITTENT CONDITION WAS FOUND TO THE POWER PRINTED CIRCUIT BOARD. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. IT WAS ALLEGED A CALL SERVICE 120 ALARM WAS EMITTED. 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
    131581 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR