BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELO GLUCOSE BIOSENSOR SYSTEM

    MDR report key: 21922729 · Received April 28, 2025

    Report

    Report Number
    3004753838-2025-100509
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    March 31, 2025
    Report Date
    August 8, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    SAF
    UDI-DI
    00386270003584
    PMA / PMN Number
    K234070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2025-100509 WAS REPORTED IN ERROR. PLEASE DISREGARD 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

    AFTER SUBMISSION OF THE INITIAL MDR PRODUCT WAS RECEIVED ON 04/09/2025 IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE BACK OF UPPER ARM ON (B)(6) 2025. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. 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
    1428823 STELO GLUCOSE BIOSENSOR SYSTEM CONTINUOUS GLUCOSE MONITOR SAF DEXCOM, INC. 9500-174 1724176004 00386270003584

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female