BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 24746851 · Received March 31, 2026

    Report

    Report Number
    3004753838-2026-123500
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 27, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2026-123500 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). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND/OR DIABETIC KETOACIDOSIS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. A CORRECTION WAS ENTERED ON (B)(6) 2026. ALTHOUGH THE PATIENT EXPERIENCED A SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THERE WAS NO DEXCOM DEVICE MALFUNCTION THAT CONTRIBUTED TO THE EVENT AND NO ALLEGATIONS MADE AGAINST DEXCOM. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION OCCURRED. THE PATIENT REPORTED THEY WERE USING A TANDEM PUMP WHEN THEY WENT INTO DIABETIC KETOACIDOSIS AND WAS TAKEN TO THE HOSPITAL. THE PATIENT DID NOT PROVIDE FURTHER EVENT DETAILS REGARDING THE ISSUE WITH THE DEXCOM, SYMPTOMS OR TREATMENT INFORMATION. FOLLOW UP ATTEMPTS TO GATHER ADDITIONAL INFORMATION WAS UNSUCCESSFUL. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63467 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Other INSULIN PUMP.