BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19887426 · Received August 1, 2024

    Report

    Report Number
    3004753838-2024-190073
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 6, 2024
    Report Date
    August 27, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270003584
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2024-190073 WAS REPORTED IN ERROR, PLEASE DISREGARD THE INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    UPDATING MDR DUE TO NON-REPORTABLE MISUSE. COMPLAINT IS NOT REPORTABLE PER CORPFT-140202.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEXCOM APP CRASH OCCURRED. NO DATA OR PRODUCT WAS PROVIDED FOR EVALUATION. 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
    957955 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-160 1723356001 00386270003584

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female