BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10983952 · Received December 10, 2020

    Report

    Report Number
    3004753838-2020-153123
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 22, 2019
    Report Date
    July 19, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000620
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2020-153123 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    Description of Event or Problem · 0

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "PAIR NEW TRANSMITTER" MESSAGE OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED AS A "PAIR NEW TRANSMITTER" MESSAGE WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE A TRANSMITTER FAILED ERROR. THE REPORTED EVENT OF A "PAIR NEW TRANSMITTER" MESSAGE IS REPORTABLE BASED ON THE FINDING OF A TRANSMITTER FAILED ERROR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453680 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 7260095 00386270000620

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR