BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4250161 · Received November 14, 2014

    Report

    Report Number
    2531779-2014-32650
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    October 23, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/18/2014 WITH THE FOLLOWING FINDINGS: DURING TESTING THE PUMP POWERED ON WITH AUDIBLE TONES AND VIBRATION BUT THE DISPLAY SCREEN REMAINED BLANK. THE KEYPAD RESPONSE WAS UNABLE TO BE TESTED DUE TO THE BLANK DISPLAY SCREEN. A LEAK TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE LEAKING FROM THE BATTERY COMPARTMENT AND THE DISPLAY SCREEN. THE PUMP WAS OPENED AND MOISTURE WAS OBSERVED IN THE BATTERY COMPARTMENT, BEHIND THE DISPLAY SCREEN AND ON THE PRINTED CIRCUIT BOARD. NO CONCLUSIONS COULD BE MADE RELATED TO THE COMPLAINT BECAUSE TESTING OF THE KEYPAD WAS UNABLE TO BE COMPLETED.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE UP, DOWN, AND OK BUTTONS WERE UNDER RESPONSIVE TO BUTTON PRESSES. THE REPORTER INDICATED THAT MOISTURE WAS OBSERVED BEHIND THE PUMP DISPLAY SCREEN LENS. 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
    738059 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1