BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8906500 · Received August 19, 2019

    Report

    Report Number
    3004753838-2019-060647
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    July 21, 2019
    Report Date
    August 19, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INACCURACIES BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND BLOOD GLUCOSE (BG) METER AND AN ADVERSE EVENT. THE PATIENT REPORTED THAT SUNDAY EVENING, HIS CGM VALUE WAS 80 MG/DL, DISPLAYED A DOWN ARROW AND THE VALUED DROPPED TO 40 MG/DL. HE REMAINED ALERT, SELF-TREATED WITH A SODA CONTAINING ADDITIONAL SUGAR FOLLOWED BY EATING TWO TABLESPOONS OF HONEY. HIS CGM CONTINUED TO ALARM FOR LOW SO HE WENT TO THE EMERGENCY DEPARTMENT (ED) FOR EVALUATION. HIS BG IN THE ED WAS 600 MG/DL. HE WAS EVALUATED AND HE WAS GOING TO BE TREATED WITH INSULIN IN THE ED, HE DECLINED AND STATED THAT HE WOULD TAKE HIS OWN INSULIN WHEN HE RETURNED HOME. THE PATIENT WAS DISCHARGED HOME, SELF-TREATED WITH INSULIN AND HIS BLOOD GLUCOSE DECREASED TO 200 MG/DL BY 6:30 AM THE FOLLOWING MORNING. AT THE TIME OF CONTACT, THE PATIENT WAS DISCHARGED HOME AND ALERT. DATA WAS PROVIDED FOR INVESTIGATION AND THE ALLEGATION AND PROBABLE CAUSE WAS UNDETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701531 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9500-27 7254959 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other