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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 9500-27
Device Problems Imprecision (1307); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter. The sensor was inserted at the abdomen on (b)(6) 2018. Reportedly, the patient did not calibrate after the inaccuracy. No additional event or patient information is available. No data was provided for evaluation. Confirmation of the reported inaccuracy could not be determined. A probable cause could not be determined. Labeling indicates: if the cgm values are outside the 20/20 range, calibrate again.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key7589732
MDR Text Key110739629
Report Number3004753838-2018-063159
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 05/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/18/2019
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5233075
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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