BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4110635 · Received September 23, 2014

    Report

    Report Number
    2531779-2014-27155
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    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)(6).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/25/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX AND ALARM HISTORY REVEALED SEVERAL CONSECUTIVE CALL SERVICE (CS) 052/CS054 ALARMS . DURING EVALUATION, THERE WERE NO ¿CS052/CS054¿ ALARMS OR ANY ERRORS, ALARMS OR WARNINGS THAT OCCURRED. THE REPORTED ¿CS052/CS054/SLEEP¿ WAS UNABLE TO BE DUPLICATED DURING INVESTIGATION. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AT THE CASE SEAL. THE PUMP¿S COVER WAS REMOVED; THERE WERE NO INTERMITTENT CONDITIONS FOUND TO THE PCB OR TO THE CGM CIRCUIT. ALSO UNRELATED TO THE COMPLAINT, THE TEXT ON THE DISPLAY SCREEN WAS FOUND TO BE DIM AND FADED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 052/053/054/055 SLEEP) 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
    589778 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1