BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3931645 · Received July 14, 2014

    Report

    Report Number
    2531779-2014-19850
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 26, 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/18/2014 WITH THE FOLLOWING FINDINGS: 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. A REVIEW OF THE PUMP BLACK BOX DATA REVEALED MULTIPLE CS 087 CALL SERVICE ALARMS. DURING TESTING, THE PUMP WAS POWERED ON AND IMMEDIATELY EMITTED A CS 069 CALL SERVICE ALARM, WHICH IS INDICATIVE OF THE SAME FAILURES THAT CAUSE THE ALARM FOUND IN THE BLACK BOX, THAT COULD NOT BE CLEARED. A SUSPECT COMPONENT ON THE PRINTED CIRCUIT BOARD WAS REPLACED AND REPROGRAMMED, AND THE PUMP POWERED ON AND WAS EXERCISED PROPERLY WITH NO FURTHER ALARMS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) 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
    410959 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1