BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM PQF

    MDR report key: 7378094 · Received March 28, 2018

    Report

    Report Number
    3004753838-2018-31227
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    February 27, 2018
    Report Date
    February 28, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    SR (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, THE PATIENT EXPERIENCED A LOSS OF CONNECTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE COMPLAINT AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE COMPLAINT TRANSMITTER DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. A VOLTAGE TEST WAS PERFORMED AND IT PASSED. A PAIRING TEST WAS PERFORMED AND IT FAILED. NO DATA AVAILABLE FOR REVIEW. THE REPORTED EVENT LOSS OF CONNECTION WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221578 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM PQF CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 6006335

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR