BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE SYSTEM

    MDR report key: 7470064 · Received April 27, 2018

    Report

    Report Number
    3004753838-2018-044972
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    April 6, 2018
    Report Date
    April 6, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    UDI-DI
    00386270000125
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT OR PROBLEM DESCRIPTION - ADDITIONAL INFORMATION. DEVICE PRODUCT CODE - CORRECTION TO OYC. DATE RECEIVED BY MANUFACTURER - ADDITIONAL INFORMATION. CORRECTION, ADDITIONAL INFORMATION, DEVICE EVALUATION. DEVICE EVALUATED, EVALUATION SUMMARY ATTACHED. METHOD CODES - ADD 10, 38, 3329; REMOVE 3263, 3331 - ADDITIONAL INFORMATION/CORRECTION. RESULT CODES - ADD 213; REMOVE 3233 - ADDITIONAL INFORMATION. CONCLUSION CODES - ADD 94; REMOVE 11 - ADDITIONAL INFORMATION. CORRECTED DATA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED: (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED, AND NO DEFECT WAS FOUND. VOLTAGE TESTING WAS PERFORMED AND FAILED. A REVIEW OF THE DATA LOG WAS NOT PERFORMED AS THERE WAS NO DATA AVAILABLE. CONFIRMATION OF THE ISSUE WAS UNDETERMINED.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. PRODUCT HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DEVICE INVESTIGATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310463 ANIMAS VIBE SYSTEM CONTINUOUS GLUCOSE MONITOR OYC DEXCOM, INC. 9438-05 5231965 00386270000125

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR