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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
Model Number 9500-27
Device Problems Use of Device Problem (1670); Invalid Sensing (2293)
Patient Problems Headache (1880); Hypoglycemia (1912); Coma (2417)
Event Date 11/25/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) diabetes mellitus is a known cause of hypoglycemia.
 
Event Description
Dexcom was made aware on 11/28/2016, that on (b)(6) 2016, the patient's continuous glucose monitoring (cgm) had inaccuracies compared to blood glucose (bg) meter, in addition to an adverse event. The sensor was inserted in the abdomen on (b)(6) 2016. The patient was on a cruise and had a hypoglycemic event. The patient had a cough and was not feeling ok. The patients head was hurting and she took tylenol for the headache. The patient's receiver was saying she was at 234 mg/dl so she took 3 units of novolog and was put into a diabetic coma about 2 hours later. The patient's husband called the medical team on the ship. The patient was put on oxygen and given a glucagon. The patient then woke up. The patient was at 18 mg/dl when the medical team arrived. The patient was put on a gurney and was taken to the medical facilities and the patient was there for about 2 hours. The patient ate a tuna sandwich and was released when she was at 188 mg/dl. At time of contact the patient was doing well. No additional even or patient information is available. No product was provided for evaluation. The reported event could not be confirmed. A root cause cannot be determined. The patient took medication(s) containing acetaminophen. Labeling indicates: taking medications with acetaminophen (such as tylenol or excedrin extra strength) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and is different for each person. The patient made treatment decisions based on cgm values. Labeling indicates: the dexcom cgm system does not replace your bg meter. When making treatment decisions, such as the amount of insulin you need, only use your bg value. Don't use the dexcom cgm system sensor glucose readings because readings can be different from your bg value. If sensor glucose readings are used in determining treatments, it could result in you missing a severe low or high glucose event. The patient did not wash hands prior to taking a finger stick. Labeling indicates: wash and dry your hands before taking a fingerstick measurement.
 
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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 Key6204739
MDR Text Key63310551
Report Number3004753838-2016-88471
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
Report Date 11/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-27
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 Received11/28/2016
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: 12/27/2016 Patient Sequence Number: 1
Treatment
NOVOLOG (3 UNITS); TYLENOL
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