BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4192635 · Received October 22, 2014

    Report

    Report Number
    2531779-2014-29971
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/05/2015 AS FOLLOWS: THE PUMP POWERED ON WITH A CALL SERVICE ALARM WHICH INDICATED AN ILLEGAL BATTERY WARNING AND WHICH PROHIBITED FURTHER TESTING. THE BLACK BOX SHOWED CONSECUTIVE ASSOCIATED CALL SERVICE ALARMS ON (B)(6) 2014. THE RETURNED BATTERY CAP AND CARTRIDGE CAP WERE USED TO COMPLETE THE INVESTIGATION WITH NO VISIBLE MALFUNCTIONS OBSERVED. THE PUMP COVER WAS REMOVED FOR FURTHER INVESTIGATION AND THE REFERENCE VOLTAGE WAS FOUND TO BE BELOW SPECIFICATION. A SUSPECT INTERNAL COMPONENT WAS REMOVED, AND THE REFERENCE VOLTAGE RETURNED TO SPECIFICATION. THE PUMP WAS THEN ABLE TO POWER UP AND BE EXERCISED WITH NO FURTHER ALARMS. 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.

    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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. NO ADDITIONAL INFORMATION WAS AVAILABLE. 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
    671382 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1