BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3210935 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09807
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 10, 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

    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

    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 PUMP WAS INTACT WITHOUT VISIBLE DAMAGE. THE BATTERY CAP THAT WAS RETURNED WITH THE PUMP FOR INVESTIGATION WAS ABLE TO MAINTAIN AN ELECTRICAL CONNECTION WHEN SECURED TO THE PUMP. THE PUMP WAS NOT ABLE TO POWER ON. A LEAK TEST WAS PERFORMED WHICH REVEALED A LEAK AT THE DISPLAY LENS. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED MOISTURE CORROSION ON THE PRINTED CIRCUIT BOARD AND INTERIOR COMPONENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING ON (B)(6) 2013 AFTER HE WENT SWIMMING, THE DISPLAY SCREEN WAS FOGGY AND THE PUMP POWERED OFF. THE PUMP REPORTEDLY WAS UNABLE TO TO POWER BACK UP. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED POWER ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312116 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR