BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM FOLLOW APP

    MDR report key: 19827562 · Received July 25, 2024

    Report

    Report Number
    3004753838-2024-181069
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 25, 2024
    Report Date
    August 20, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2024-181069 WAS REPORTED IN ERROR, PLEASE DISREGARD THE INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    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.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349181 DEXCOM FOLLOW APP CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female