BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7081760 · Received December 4, 2017

    Report

    Report Number
    2531779-2017-27510
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Report Date
    November 11, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 09-JAN-2018. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 15-DEC-2017 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED EVIDENCE OF A CALL SERVICE 052, 060, AND 087 ALARMS. THE PUMP POWERED UP WITH THE RETURNED BATTERY CAP TO A BLANK DISPLAY. THE PUMP WAS OPENED TO FIND INTERNAL MOISTURE. THE CALL SERVICE ALARM ISSUE WAS UNABLE TO BE DUPLICATED DURING INVESTIGATION DUE TO THE BLANK DISPLAY.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS AND REPORTED THAT CALL SERVICE ALARM [060-YYYY] 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
    859916 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR