BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004753838-2018-020414

    MDR report key: 7301227 · Received February 27, 2018

    Report

    Report Number
    3004753838-2018-020414
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Date of Event
    January 29, 2018
    Report Date
    January 30, 2018
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2018. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE PROBLEM AND PROBABLE CAUSE COULD NOT BE DETERMINED. LABELING INDICATES: DO NOT INSERT THE SENSOR IN SITES OTHER THAN THE BELLY (ABDOMEN) OR UPPER BUTTOCKS. USE IN OTHER SITES MIGHT CAUSE SENSOR GLUCOSE READINGS TO BE INACCURATE AND COULD RESULT IN YOU MISSING SEVERE HYPOGLYCEMIA (LOW BLOOD GLUCOSE) OR HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) EVENTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR