BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22398422 · Received July 3, 2025

    Report

    Report Number
    3004753838-2025-172229
    Event Type
    Injury
    Date Received
    July 3, 2025
    Date of Event
    June 14, 2025
    Report Date
    August 19, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004055
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS.

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2025-172229 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 AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. ACCORDING TO THE PATIENT, ON APPROXIMATELY (B)(6) 2025, THE CGM READING WAS DISPLAYING LOW FOR 14 HOURS. NO SPECIFIC CGM READING WAS REPORTED. DURING THIS TIME THE PUMP DID NOT ADMINISTER INSULIN, WHICH CAUSED THE PATIENT TO EXPERIENCE DIABETIC KETOACIDOSIS. NO SPECIFIC SYMPTOMS WERE REPORTED. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED, BUT NO SPECIFIC INFORMATION REGARDING THE DURATION OF THE STAY AT THE HOSPITAL WAS REPORTED. MEDICAL OR SURGICAL TREATMENT WOULD HAVE BEEN NECESSARY, BUT NO SPECIFIC TREATMENT WAS REPORTED. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    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
    1856122 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI 00386270004055

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| O T:SLIM X2 INSULIN PUMP