BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3930234 · Received July 11, 2014

    Report

    Report Number
    2531779-2014-19796
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    June 24, 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 DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/03/2014 WITH THE FOLLOWING FINDINGS: THE THREADS ON THE RETURNED BATTERY CAP WERE OBSERVED TO BE STRIPPED AND THE CAP WAS DIFFICULT TO REMOVE FROM THE PUMP BECAUSE OF THE STRIPPED THREADS. THE BATTERY CAP CONTACT FOR HEIGHT AND WIDTH WERE WITHIN SPECIFICATIONS. NO DAMAGE WAS FOUND TO THE BATTERY CHAMBER THREADS. A TEST CAP WAS INSERTED AND WAS ABLE TO BE FULLY TIGHTENED UNTIL THE O-RING WAS SEATED AND THE CAP WAS FLUSH WITH THE PUMP CASE. THERE WAS NO ISSUE WITH REMOVING THE TEST CAP FROM THE PUMP DURING TESTING. 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 CASING/CONDITION (DAMAGED CAP AND CASE) ISSUE. THIS COMPLAINT IS AGAINST THE BATTERY CAP ALONE. THE REPORTER STATED THAT THE BATTERY CAP WAS IN THE LOCKED POSITION AND COULD NOT BE REMOVED. 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
    406484 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1