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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

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Catalog Number STS-GL-011
Device Problem Invalid Sensing (2293)
Patient Problem Seizures (2063)
Event Date 02/12/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The g5 system is associated with product code pqf. Product code pqf is not currently available in common device name.
 
Event Description
Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the patient experienced continuous glucose monitoring (cgm) inaccuracies and an adverse event. Sensor was inserted at the abdomen on (b)(6) 2017. Patient reported experiencing a seizure. Patient asserts that the seizure was due to the inaccuracies. Patient reported cgm blood glucose (bg) value was 381 mg/dl, while a bg meter value was 196 mg/dl. There was no report of medical intervention. At time of contact, patient is stable. No additional event or patient information is available. No product or data was provided for investigation. The reported issue could not be confirmed. The root cause could not be determined.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE 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
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key6381932
MDR Text Key69178081
Report Number3004753838-2017-15886
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019(241)9500-27(10)NI(17)NI
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 02/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSTS-GL-011
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 Received02/12/2017
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 Treatment Data
Date Received: 03/06/2017 Patient Sequence Number: 1
Treatment
AMLODIPINE BESYLATE; ATROVASTATIN; HYDROCHLOROTHIAZIDE; MYLANTA; SYNTHROID
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