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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 MDS

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number 9500-44
Device Problem Invalid Sensing (2293)
Patient Problems Fatigue (1849); Malaise (2359)
Event Date 05/22/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Distributor contacted dexcom on (b)(6) 2016 to report that the patient experienced continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter on (b)(6) 2016. The sensor was inserted on (b)(6) 2016. It was reported that on (b)(6) 2016, a day after sensor insertion, the patient was feeling very tired and ill. The dexcom cgm indicated that his bg was 5. 4mmol/l with a 45 degree down arrow showing. The patient then did a fingerstick and his actual bg was 2. 4mmol/l. After rectifying his glucose, the cgm was recalibrated and the patient's father continued to double check his readings regularly over the next 48 hours with fingerstick tests. The sensor regained accuracy after about 36 hours and then managed to last the full 7 day without further problems, however the accuracy was never quite what had come to be expected from dexcom.
 
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Brand NameDEXCOM G4 PLATINUM 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 Key5790258
MDR Text Key49413790
Report Number3004753838-2016-26631
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 06/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/06/2017
Device Model Number9500-44
Device Catalogue NumberSTS-GF-004
Device Lot Number5208572
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 Received06/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/07/2016
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: 07/13/2016 Patient Sequence Number: 1
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