BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8899708 · Received August 15, 2019

    Report

    Report Number
    3004753838-2019-060278
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    March 4, 2019
    Report Date
    August 15, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000323
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PAIRING FAILURE OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A RECEIVER CHARGES AND BOOT UP WAS PERFORMED AND PASSED. A DOWNLOAD RX LOG AND PERFORM REVIEW OF THE RX LOG WAS PERFORMED AND REVEALS THAT THE PATIENT REPORTED THAT THE SMART PHONE AND/OR RECEIVER UNIT (B)(4) FAILED TO PAIR WITH TX UNIT(S) 41WF2J ON (B)(6) 2019. IT ALSO REVEALED THAT THE PATIENT ATTEMPTED TO PAIR A TX UNIT THAT HAD PREVIOUSLY SENT A LOW TRANSMITTER BATTERY ALARM AND A SCREEN TRANSMITTER ERROR ALARM TO THE SMART DEVICE AND\OR RX UNIT. WHEN A TX UNIT HAD ALREADY SENT A LOW TRANSMITTER BATTERY AND A SCREEN TRANSMITTER ERROR ALARM TO THE SMART DEVICE AND\OR RX UNIT. TX UNIT WILL NEVER BE ABLE TO PAIR WITH THE SMART DEVICE AND\OR RX UNIT. A TEST ON THE RECEIVER FUNCTIONAL TEST STATION WAS PERFORMED AND PASSED. A PERFORM PARING\CALIBRATION AND PERFORMANCE TEST WAS PERFORMED AND PASSED. AFTER PERFORMING THE FFA LAB PARING\CALIBRATION\PERFORMANCE\RANGE TEST WITH THE RX UNIT (B)(4) THAT THE CUSTOMER SENT BACK WITH A GOOD KNOW TX EMULATOR 400011, FFA LAB COULD NOT FIND ANYTHING WRONG WITH RX UNIT (B)(4). DURING THE ENTIRE FFA LAB PAIRING\CALIBRATION\PERFORMANCE\RANGE TEST, THE RETURNED RX (B)(4) UNIT AND THE GOOD KNOWN TX EMULATOR 400011 WERE ~20 FT APART.A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A PAIRING FAILURE WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE LOSS OF CONNECTION. IN ADDITION, THE PROBABLE CAUSE OF THE LOSS OF CONNECTION WAS FOUND TO BE A DEFECTIVE TRANSMITTER. THE REPORTED EVENT OF A PAIRING FAILURE IS REPORTABLE BASED ON THE FINDING OF A DEFECTIVE TRANSMITTER. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691294 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22949 5234958 00386270000323

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR