BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 14286135 · Received May 5, 2022

    Report

    Report Number
    3004753838-2022-071638
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 2, 2022
    Report Date
    July 21, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, AFTER FURTHER REVIEW OF THE COMPLAINT RECORD, IT WAS DETERMINED THAT THE PATIENT DID NOT HAVE TRANSMITTER FAILED/ERROR/ALERT. REPORT WAS SUBMITTED IN ERROR. PLEASE DISREGARD ALL INFORMATION IN MFR 3004753838-2022-071638 AS THIS WILL NOT BE REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND PASSED. PAIRING TEST WAS PERFORMED AND FAILED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND TRANSMITTER FAILED ERROR WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, AFTER FURTHER REVIEW OF THE COMPLAINT RECORD, IT WAS DETERMINED THAT THE PATIENT DID NOT HAVE TRANSMITTER FAILED/ERROR/ALERT. REPORT WAS SUBMITTED IN ERROR. PLEASE DISREGARD ALL INFORMATION IN MFR 3004753838-2022-071638 AS THIS WILL NOT BE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822559 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-18 5299442

    Patients

    Seq Age Sex Outcome Treatment
    1 Female