BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19001242 · Received March 28, 2024

    Report

    Report Number
    3004753838-2024-073353
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    March 2, 2024
    Report Date
    April 2, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. 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, A CORRECTION WAS UPDATED ON 3/29/2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT WHILE USING A DIABELOOP DBLG1 CLOSED-LOOP SYSTEM, WHICH OCCURRED 6 DAYS AFTER THE SENSOR WAS INSERTED IN THE ARM. ON (B)(6) 2024, THE DAY OF THE EVENT, THE PATIENT RECEIVED A WARNING ON THE DBLG1 SYSTEM BUT WAS UNABLE TO REMEMBER WHAT TYPE OF WARNING IT WAS. AT AN UNKNOWN TIME AFTER THIS THE PATIENT LOST CONSCIOUSNESS. AN AMBULANCE WAS CALLED BY THE PATIENT´S HUSBAND AND WHEN THE PARAMEDICS ARRIVED A FINGERSTICK WAS TAKEN AND THE BLOOD GLUCOSE READING WAS 42 MG/DL, IT IS NOT KNOWN WHAT THE CGM (CONTINUOUS GLUCOSE MONITOR) DEVICE WAS DISPLAYING AT THAT MOMENT. THE PATIENT WAS GIVEN INTRAVENOUS TREATMENT WITH GLUCOSE. IT WAS NOT REPORTED THAT MORE TREATMENT WAS NEEDED, AND IT WAS STATED THAT THE PATIENT DID NOT NEED TO GO TO THE HOSPITAL. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. NO OTHER DETAILS WERE DOCUMENTED, AND THE PATIENT DID NOT REMEMBER MORE DETAILS REGARDING THE EVENT. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. A REVIEW OF PERFORMANCE DATA SHOWS THAT THE PATIENT DID NOT EXPERIENCE ANY SIGNIFICANT OR LONG-TERM ISSUE THAT WOULD HAVE CAUSED A DISRUPTION IN HER CGM READINGS ON OR AROUND THE ALLEGED ISSUE DATE OF (B)(6) 2024. DATA INVESTIGATION ALSO SHOWS THAT THE PATIENT'S EGVS (ESTIMATED GLUCOSE VALUE) DID NOT DROP LOWER THAN 84 MG/DL AT ANY POINT ON THIS DAY. MOREOVER, DURING THE ALLEGED TIME OF THE INCIDENT AT 1:00 PM, THE PATIENT'S ESTIMATED GLUCOSE VALUES WERE OBSERVED TO BE READING AROUND 100 MG/DL DESPITE THE PATIENT HAVING ALLEGED A BLOOD GLUCOSE METER VALUE OF LESS THAN 42 MG/DL. THUS, INACCURATE ESTIMATED GLUCOSE VALUES HAVE BEEN DETERMINED TO BE THE MOST LIKELY THE ROOT CAUSE OF THE HYPOGLYCEMIC EVENT. NO OTHER PATIENT OR EVENT DETAILS WERE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2253705 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1723323001

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other DIABELOOP DBLG1 CLOSED-LOOP SYSTEM