BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 12555198 · Received September 30, 2021

    Report

    Report Number
    3004753838-2021-178345
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    September 8, 2021
    Report Date
    October 29, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COM-(B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4) ¿FOLLOW-UP NUMBER¿ FIELD UPDATED FROM [¿N¿] TO [¿N+1¿] AS THE SUPPLEMENTAL REPORT SUBMITTED UNDER FOLLOW-UP NUMBER [¿N¿] FAILED DUE TO AN ERROR WITH THE AS2 CERTIFICATE, WHICH HAS SINCE BEEN CORRECTED.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. DATA WAS RECEIVED FOR EVALUATION. HOWEVER, THE ALLEGED PRODUCT IS NOT PRESENT WITHIN THE INVESTIGATION WINDOW. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. DATA WAS RECEIVED FOR EVALUATION. HOWEVER, THE ALLEGED PRODUCT IS NOT PRESENT WITHIN THE INVESTIGATION WINDOW. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. DATA WAS RECEIVED FOR EVALUATION. HOWEVER, THE ALLEGED PRODUCT IS NOT PRESENT WITHIN THE INVESTIGATION WINDOW. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454450 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-24 7286393

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR