BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELO GLUCOSE BIOSENSOR SYSTEM

    MDR report key: 21336930 · Received February 7, 2025

    Report

    Report Number
    3004753838-2025-033099
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    December 31, 2024
    Report Date
    June 11, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    SAF
    PMA / PMN Number
    K234070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL INFORMATION. D9: DEVICE - ADDITIONAL INFORMATION. E1 INITIAL REPORTER FIRST NAME - ADDITIONAL INFORMATION. E1 INITIAL REPORTER LAST NAME - ADDITIONAL INFORMATION. E1 INITIAL REPORTER EMAIL ADDRESS - ADDITIONAL INFORMATION. E1 INITIAL REPORTER STREET LINE 1 - ADDITIONAL INFORMATION. E1 INITIAL REPORTER COUNTRY CODE - ADDITIONAL INFORMATION. E1 INITIAL REPORTER CITY- ADDITIONAL INFORMATION. E1 INITIAL REPORTER STATE - ADDITIONAL INFORMATION. E1 INITIAL REPORTER ZIP CODE - ADDITIONAL INFORMATION. E1 INITIAL REPORTER TELEPHONE NUMBER - ADDITIONAL INFORMATION. G3: DATE RECEIVED BY MANUFACTURER- ADDITIONAL INFORMATION. H2: ADDITIONAL INFORMATION. H3 REASON FOR NON-EVALUATION - ADDITIONAL INFORMATION. H6: ADVERSE EVENT PROBLEM COMPONENT CODES ¿ ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2025-033099 WAS REPORTED IN ERROR. PLEASE DISREGARD 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 DETACHED NEEDLE OR CANNULA OCCURRED. THE SENSOR WAS INSERTED INTO THE BACK OF UPPER ARM ON (B)(6) 2024. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104822 STELO GLUCOSE BIOSENSOR SYSTEM CONTINUOUS GLUCOSE MONITOR SAF DEXCOM, INC. 9500-174 1724186001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown