BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4123682 · Received September 26, 2014

    Report

    Report Number
    3004753838-2014-29286
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014, UPON REMOVAL OF SENSOR POD, SENSOR WIRE BROKE AND A PORTION REMAINED LEFT BEHIND AT SITE OF INSERTION. PATIENT STATED THEY EXPERIENCED "SLIGHT PAIN." PATIENT SAW PHYSICIAN'S ASSISTANT WHO DID NOT FIND ANY FRAGMENT OF SENSOR WIRE UNDER THE SKIN BUT PRESCRIBED ANTIBIOTIC JUST IN CASE. PATIENT DID NOT REPORT ANY INJURY OR FURTHER MEDICAL INTERVENTION AT TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600289 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5140391

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other