BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8215426 · Received January 3, 2019

    Report

    Report Number
    3004753838-2019-00934
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 8, 2018
    Report Date
    January 3, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) DATE OF EVENT - CORRECTION "(B)(6)-2018" DESCRIBE EVENT OR PROBLEM - CORRECTION "DEXCOM WAS MADE AWARE ON 12/09/2018, THAT ON (B)(6)2018, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER."

    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 AT THE ABDOMEN ON (B)(6) 2018. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS RECEIVED FOR EVALUATION BUT FURTHER INVESTIGATION CANNOT BE COMPLETED TO CONFIRM THE REPORTED ISSUE. THE COMPLAINT CONFIRMATION OF THE REPORTED INACCURACY COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 12/09/2018, THAT ON (B)(6) 2018, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7422 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9500-44 5239851

    Patients

    Seq Age Sex Outcome Treatment
    1