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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 Imprecision (1307)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred.The sensor was inserted into the abdomen on (b)(6) 2022.No data was provided for evaluation.The allegation and a probable cause could not be determined.It has been reported that there was a difference in readings of 100 points.There were no reported glucose values available to search within the parkes error grid calculator.No injury or medical intervention was reported.
 
Event Description
Subsequent to the initial mdr, a correction is required.
 
Manufacturer Narrative
(b)(4).
 
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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 Key14403428
MDR Text Key300156665
Report Number3004753838-2022-078915
Device Sequence Number1
Product Code QII
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K191833
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/26/2022
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 04/14/2022
Initial Date FDA Received05/14/2022
Supplement Dates Manufacturer Received05/22/2022
Supplement Dates FDA Received05/26/2022
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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