BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8773448 · Received July 9, 2019

    Report

    Report Number
    3004753838-2019-052626
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    June 13, 2019
    Report Date
    March 27, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000613
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR (3004753838-2019-052626) WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NON-REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECEIVER CEASED TO FUNCTION. 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

    THE RECEIVER WAS RETURNED FOR EVALUATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED BECAUSE THE USB PIN(S) FROM J3 WERE DAMAGED. PICTURES WERE TAKEN. A RECEIVER CHARGE AND BOOT WAS PERFORMED AND FAILED BECAUSE THE USB PIN(S) FROM J3 WERE DAMAGED. THE LOG WAS NOT DOWNLOAD FOR REVIEW BECAUSE THE USB PIN(S) FROM J3 WERE DAMAGED. THE RECEIVER CASE WAS OPENED, AND AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. CONFIRMATION OF THE COMPLAINT WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567074 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22719 5232080 00386270000613

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR