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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number MT20649-2
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on 07/07/2016, that on (b)(6) 2016 the receiver display malfunctioned. There was no report of any injury or medical intervention. No additional event or patient information is available. Complaint device was returned for evaluation. A visual exterior inspection was performed on the receiver and it passed. A receiver functional test was performed on the receiver and it passed. Receiver data logs were downloaded and reviewed, finding a hardware error, a screen error alarm, and multiple firmware errors. Based on the finding of multiple firmware errors this is being reported. The complaint was confirmed. The root cause could not be determined post investigation.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key6535615
MDR Text Key74167790
Report Number3004753838-2017-27365
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 07/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-2
Device Catalogue NumberSTK-GL-117
Device Lot Number5209306
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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