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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9500-35
Device Problem Imprecision (1307)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/15/2020
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.No data was provided for evaluation.Confirmation of the allegation and a probable cause could not be determined.It has been reported that there was a difference in readings of 10-15 mmol/l points.There were no reported glucose values available to search within the parkes error grid calculator.No injury or medical intervention was reported.
 
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Brand Name
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING 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 Key10180821
MDR Text Key196099134
Report Number3004753838-2020-060958
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number9500-35
Device Catalogue NumberSTS-GL-006
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/16/2020
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
Patient Age118 YR
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