BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4774742 · Received May 15, 2015

    Report

    Report Number
    2531779-2015-16201
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Report Date
    April 30, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 06/30/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/23/2015 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA AND PUMP ALARM HISTORY REVEALED RECORDS OF CALL SERVICE ALARM (012-0195). ON INVESTIGATION, EZ-PRIME WAS PERFORMED SUCCESSFULLY WITHOUT CALL SERVICE ALARM, WARNING, ERROR OR ALARM. THE PUMP WAS EXERCISED FOR 24 HOURS AND FOUND TO BE OPERATING WITHIN THE REQUIRED SPECIFICATION WITHOUT MALFUNCTION. THE PUMP WAS OPENED FOR FURTHER INVESTIGATION AND DID NOT REVEAL ANY DAMAGE, DEFECT OR CONTAMINATION OF THE PUMP¿S INTERIOR COMPONENTS. INVESTIGATION DID NOT DUPLICATE THE COMPLAINT. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY WAS NOTED TO BE DIM/FADED/DISCOLORED.

    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).

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 012) 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
    319355 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1