BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3120010 · Received May 20, 2013

    Report

    Report Number
    2531779-2013-06677
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 INVESTIGATION, THE PUMP POWERED ON WITH A FULLY ILLUMINATED AND LEGIBLE DISPLAY SCREEN WITHOUT DISCOLORATION. THE PUMP WAS OPENED FOR INVESTIGATION AND DID NOT REVEAL ANY EVIDENCE OF INTERNAL DAMAGE, DEFECT OR CONTAMINATION. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT OF A BLANK DISPLAY SCREEN.

    Additional Manufacturer Narrative · 1

    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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTER CONTACTED ANIMAS AND REPORTED A BLANK DISPLAY SCREEN. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. IT WAS NOTED THAT THE PUMP WAS VIBRATING AND THERE WAS AUDIBLE TONES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221389 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1