BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3895721 · Received June 25, 2014

    Report

    Report Number
    2531779-2014-18318
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 17, 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

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/31/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX AND ALARM HISTORY SHOWED A CALL SERVICE ALARM ON 03/11/2014. THERE WERE NO CALL SERVICE ALARMS OR ANY OTHER WARNINGS OCCURRING DURING THE INVESTIGATION; THE PRODUCT PERFORMED WITHIN SPECIFICATION. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY WAS OBSERVED TO BE DIM AND REDDISH UPON START UP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 088) ISSUE. THE REPORTER STATED THAT A CALL SERVICE ALARM HAD OCCURRED 3 OR MORE TIMES IN THE LAST 30 DAYS. 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
    371275 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1