BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4221390 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31288
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 20, 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 DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/08/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED A CALL SERVICE ALARM ASSOCIATED WITH A HIGH FORCE DUE TO AN OCCLUSION EVENT DURING PRIME ON (B)(6) 2014. NO BATTERY CAP WAS RETURNED; A TEST BATTERY CAP AND RETURNED CARTRIDGE CAP WERE USED TO COMPLETE THE INVESTIGATION. NO CALL SERVICE ALARMS OR ANY OTHER WARNINGS OCCURRED DURING THE INVESTIGATION; THE PRODUCT PERFORMED WITHIN SPECIFICATIONS. PRODUCT ANALYSIS WAS UNABLE TO DUPLICATE THE INITIAL CALL SERVICE ALARM COMPLAINT. THE PUMP WAS OPENED FOR FURTHER INVESTIGATION AND NO INTERMITTENT CONDITION WAS FOUND TO THE MOTOR ASSEMBLY. 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 CALL SERVICE ALARM (CS 064) 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
    701435 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1