BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3942132 · Received July 17, 2014

    Report

    Report Number
    2531779-2014-20493
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/23/2014 WITH THE FOLLOWING FINDINGS:. THE REPORTED INTERMITTENT ISSUE WITH KEYPAD BUTTONS WAS NOT CONFIRMED OR DUPLICATED DURING TESTING. ALL OF THE KEYPAD BUTTONS WERE FOUND TO BE RESPONSIVE TO BUTTON PRESSES. THE BUTTONS WERE FOUND TO HAVE NORMAL SPRING BACK AND CLICK. THERE WAS NO DAMAGE FOUND TO THE KEYPAD COVER. THERE WAS NO CONTAMINATION FOUND UNDER THE BUTTON KEY CONTACTS WHEN THE KEYPAD COVER WAS REMOVED. UNRELATED TO THE COMPLAINT, THE TEXT ON THE DISPLAY SCREEN WAS FOUND TO BE DIM, FADED AND DISCOLORED. THE CONTRAST SETTING WAS SET AT '8' AND THEN INCREASED TO THE MAXIMUM SETTING OF '10' WITH LITTLE IMPROVEMENT OBSERVED. ALSO UNRELATED TO THE COMPLAINT, A HOLE WAS OBSERVED ON THE BOLUS BUTTON. HOWEVER, THE BOLUS BUTTON WAS STILL FOUND TO BE RESPONSIVE TO BUTTON PRESSES. 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 BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE UP, DOWN AND OK KEYPAD BUTTONS REPORTEDLY WERE UNDER-RESPONSIVE. 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
    420424 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1