BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3121545 · Received May 21, 2013

    Report

    Report Number
    2531779-2013-06781
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 (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: ON EXAMINATION, THE KEYPAD WAS NOTED TO BE INTACT WITHOUT DAMAGE. ON TESTING, ALL THE KEYPAD BUTTONS HAD NORMAL RESPONSE. THE KEYPAD COVER WAS REMOVED AND DID NOT REVEAL ANY EVIDENCE OF DEFECT, DAMAGE OR CONTAMINATION. INVESTIGATION WAS UNABLE TO CONFIRM OR DUPLICATE THE COMPLAINT.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS WERE UNRESPONSIVE. THE PATIENT REPORTED NOT BEING ABLE TO MOVE PAST THE VERIFY SCREEN AFTER REBOOTING THE PUMP DUE TO THE UNRESPONSIVE KEYPAD BUTTONS. THE PATIENT DENIED DAMAGE OR MOISTURE TO THE KEYPAD. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED KEYPAD MALFUNCTION REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224754 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1