BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7975157 · Received October 17, 2018

    Report

    Report Number
    3004753838-2018-125582
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    September 26, 2018
    Report Date
    September 26, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000323
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, AN "! HWW ERR" WAS DISPLAYED ON THE RECEIVER. NO PRODUCT OR DATA WAS NOT AVAILABLE FOR EVALUATION. IT WAS REPORTED THAT THE RECEIVER WAS DROPPED BY THE PATIENT. LABELING INDICATES: IF THE DEXCOM G5 RECEIVER OR DEXCOM G5 TRANSMITTER IS DAMAGED OR CRACKED, DO NOT USE IT. THIS COULD CREATE AN ELECTRICAL SAFETY HAZARD CAUSING POSSIBLE ELECTRICAL SHOCKS RESULTING IN INJURY. IN ADDITION, A DAMAGED OR CRACKED DEXCOM G5 RECEIVER OR DEXCOM G5 TRANSMITTER MAY CAUSE THE DEXCOM G5 SYSTEM NOT TO FUNCTION PROPERLY. CONFIRMATION OF THE ERROR ICON AND A 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
    813873 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22949 5234512 00386270000323

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR