BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3920134 · Received July 8, 2014

    Report

    Report Number
    2531779-2014-19351
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP 1: 08/08/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE REPORTED 'BLANK' SCREEN WAS UNABLE TO BE CONFIRMED OR DUPLICATED DURING INVESTIGATION. THE DISPLAY SCREEN WAS FOUND TO BE FUNCTIONING UPON STARTUP OF THE PUMP. UNRELATED TO THE COMPLAINT, THERE WERE MULTIPLE CALL SERVICE 012, 052 AND 054 ALARMS FOUND IN HISTORY AT THE TIME OF EVENT. THERE WAS NO POWER ON RESET EVENTS OBSERVED BEFORE THE CS 012, 052, 054 ALARMS. THE CALL SERVICE ALARM ISSUES WERE FOUND IN HISTORY BUT WERE NOT DUPLICATED DURING TESTING. ALSO UNRELATED TO THE COMPLAINT, THE TEXT ON THE DISPLAY SCREEN WAS FOUND TO BE DIM, FADED 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. 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
    397135 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1