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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 CONTINOUS GLUCOSE MONITOR

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINOUS GLUCOSE MONITOR Back to Search Results
Model Number 9500-44
Device Problem Invalid Sensing (2293)
Patient Problem Headache (1880)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the continuous glucose monitor (cgm) had inaccuracies compared to blood glucose (bg) meter in addition to an adverse event that occurred. The sensor was inserted in the patient's abdomen on (b)(6) 2016. The patient stated that she noticed that her cgm did not always seem to give a correct reading. The patient stated that last week her cgm machine told her she was at 12 and she felt unwell with a headache, so did a blood test which read 3. The patient took a glucagon pill and recovered within 15 minutes. At time of contact the patient was fully recovered. No additional event or patient information is available. No product was provided for evaluation. The reported event could not be confirmed. A root cause cannot be determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINOUS 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 Key6218612
MDR Text Key63741227
Report Number3004753838-2017-00534
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-44
Device Catalogue NumberSTS-GF-001
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 Received12/10/2016
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: 01/03/2017 Patient Sequence Number: 1
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