BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7934587 · Received October 4, 2018

    Report

    Report Number
    3004753838-2018-118262
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    September 7, 2018
    Report Date
    September 7, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000620
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)"MODEL NUMBER   9438-06 CATALOG NUMBER   STT-MC-001 (B)(4) LOT NUMBER   7237779 UNIQUE IDENTIFIER (UDI) NUMBER (B)(4)".

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW UP WILL BE SUBMITTED UPON COMPLETION OF DEVICE INVESTIGATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED AND ADDITIONAL INFORMATION IS AVAILABLE. NO DATA OR PRODUCT WAS PROVIDED FOR EVALUATION. THE PRODUCT WAS SCRAPPED AFTER INITIAL INVESTIGATION INCLUDED IN (B)(4). CONFIRMATION OF THE ISSUE WAS UNDETERMINED. 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
    777929 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22719 5227078 00386270000620

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR