BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3735981 · Received April 9, 2014

    Report

    Report Number
    3004753838-2014-07305
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 12, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, THE RECEIVER (PART MT20649/LOT 5081052), THAT WAS BEING USED WITH THE SENSOR DURING THE REPORTED EVENT OF INACCURATE BLOOD GLUCOSE LEVELS WAS RETURNED. EVALUATION OF THE RETURNED RECEIVER AND REVIEW OF THE DOWNLOADED DATA LOG DID NOT CONFIRM THE REPORTED EVENT.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT A HYPOGLYCEMIC EVENT AND CGM INACCURACIES ON (B)(6) 2014. THE PATIENT REPORTED THAT HER CGM READING WAS 78 MG/DL AND SHE PASSED OUT. PATIENT STATES HER DAUGHTER CALLED EMT. THE EMT STATED THE PATIENT'S BLOOD GLUCOSE WAS 28 MG/DL AND PATIENT WAS GIVEN A GLUCAGON SHOT. THE PATIENT WAS NOT HOSPITALIZED. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213713 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other