BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3844415 · Received June 2, 2014

    Report

    Report Number
    2531779-2014-15548
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 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. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). 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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/15/2014 WITH THE FOLLOWING FINDINGS: ON EXAMINATION, THE AUDIO BOLUS BUTTON WAS INTACT WITHOUT DAMAGE. ON TESTING, THE AUDIO BOLUS BUTTON HAD NORMAL RESPONSE. INVESTIGATION DID NOT DUPLICATE THE REPORTED INTERMITTENT RESPONSE OF THE AUDIO BOLUS BUTTON. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS NOTED TO BE CRACKED, EXTENDING DOWN BEHIND THE FINGER PAD. THE BATTERY CAP RETURNED WITH THE PUMP FIT PROPERLY ONTO THE PUMP. THERE WAS NO POWER LOSS DURING THE INVESTIGATION AND NO MOISTURE INSIDE THE BATTERY COMPARTMENT. ALSO UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY SCREEN WAS NOTED TO BE DIM, FADED AND DISCOLORED. ADJUSTMENT OF THE CONTRAST SETTINGS DID NOT RESOLVE THE DISPLAY ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (ABB TACTILE CNG/UNRESPONSIVE) 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
    321660 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1