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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 PROFESSIONAL SYSTEM; CONTINUOUS GLUCOSE MONITOR
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DEXCOM, INC. DEXCOM G6 PROFESSIONAL SYSTEM; CONTINUOUS GLUCOSE MONITOR Back to Search Results
Catalog Number STP-PR-001
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that missing sensor wire occurred.The sensor was inserted into the abdomen on (b)(6) 2024.It was indicated that the patient removed the transmitter from the sensor pod before removing the sensor from the body, which is misuse of the device.No product was provided for evaluation.The allegation and a probable cause could not be determined.No injury or medical intervention was reported.
 
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Brand Name
DEXCOM G6 PROFESSIONAL SYSTEM
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key18856805
MDR Text Key337116995
Report Number3004753838-2024-055846
Device Sequence Number1
Product Code QII
UDI-Device Identifier00386270001092
UDI-Public00386270001092
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
DEN170088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberSTP-PR-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2024
Initial Date FDA Received03/07/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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