BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8601830 · Received May 10, 2019

    Report

    Report Number
    3004753838-2019-041124
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 1, 2019
    Report Date
    May 10, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    10386270000238
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). MFR 3004753838 - 2019 - 041124 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NON-REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECEIVER HAD INTERMITTENT AUDIO OUTPUT. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392033 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22719 5235659 10386270000238

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR