BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3944387 · Received July 18, 2014

    Report

    Report Number
    2531779-2014-20647
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 11, 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 PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/22/2014 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 A LOSS OF PRIME WARNING ASSOCIATED WITH A LOW, NON-ZERO FORCE. MULTIPLE CS 078 CALL SERVICE ALARMS WERE ALSO OBSERVED IN THE BLACK BOX DATA. DURING TESTING, THE PUMP EMITTED A CS 078 CALL SERVICE ALARM DURING AN ATTEMPTED REWIND STEP. THE PUMP CASE WAS REMOVED, AND THE MOTOR ASSEMBLY WAS UNRESPONSIVE WHEN CONNECTED TO AN EXTERNAL POWER SUPPLY, REVEALING AN INTERNAL MOTOR FAILURE. FURTHER ADEQUATE INVESTIGATION COULD NOT BE COMPLETED DUE TO THE CALL SERVICE ALARM.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE WITH THE PUMP. 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
    422020 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1