BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7387659 · Received March 31, 2018

    Report

    Report Number
    3004753838-2018-033187
    Event Type
    Malfunction
    Date Received
    March 31, 2018
    Date of Event
    March 1, 2018
    Report Date
    May 6, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    10386270000221
    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). 3004753838-2018-033187 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    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

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, THE G5 MOBILE APPLICATION DISPLAYED THAT SMART DEVICE BLUETOOTH WAS OFF WHILE BLUETOOTH WAS ON. NO PRODUCT OR DATA WAS AVAILABLE FOR EVALUATION. CONFIRMATION OF THE COMPLAINT COULD NOT BE DETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230478 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 6004555 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR