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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number 9438-06
Device Problem Invalid Sensing (2293)
Patient Problem Seizures (2063)
Event Date 06/14/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter that occurred on (b)(6) 2016. The sensor was inserted on (b)(6) 2016. Patient stated that they experienced three mini seizures due to going low and the receiver displaying inaccurate bg values. Patient did not have to go to the hospital but patient's boyfriend did have to intervene. Additionally, patient reported inaccurate cgm values of 300mg/dl compared to bg meter values of 204mg/dl. No additional event or patient information was provided.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The receiver data log was reviewed on 07/13/2016. The complaint of inaccurate cgm values was confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
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
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key5788562
MDR Text Key49361116
Report Number3004753838-2016-38677
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,Followup
Report Date 06/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9438-06
Device Catalogue NumberSTT-GF-001
Device Lot Number408B8P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/12/2016 Patient Sequence Number: 1
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