BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3832702 · Received May 27, 2014

    Report

    Report Number
    2531779-2014-14822
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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

    FOLLOW-UP #1: DATE OF SUBMISSION 08/05/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX REVEALED MULTIPLE POWER ON RESET EVENTS. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AT THE THREADS AND THE BATTERY CAP WAS FOUND TO BE STRIPPED AND WAS UNABLE TO SECURE TO THE PUMP. DURING TESTING, THE PUMP WAS REBOOTING. A TEST BATTERY CAP WAS USED FOR TESTING PURPOSES. THE TEST BATTERY CAP SECURED TIGHTLY TO THE PUMP AND MAINTAINED AN ELECTRICAL CONNECTION WITH NO FURTHER POWER INTERRUPTIONS. THERE WERE NO INTERMITTENT CONDITIONS FOUND TO THE POWER CIRCUIT. UNRELATED TO THE COMPLAINT, A MISSING LINE PIXEL WAS FOUND ON THE DISPLAY. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY; THE DISPLAY FULLY ILLUMINATED AND FUNCTIONED APPROPRIATELY. 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 STATING THERE WAS AN INTERMITTENT POWER ISSUE WITH THE PUMP. THE BATTERY CAP THREADS WERE REPORTEDLY STRIPPED. THE BATTERY COMPARTMENT WAS REPORTEDLY CRACKED. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310829 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR