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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 Problem Invalid Sensing (2293)
Patient Problems Hypoglycemia (1912); Lethargy (2560)
Event Date 02/14/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia. Product classification code pqf is not currently available.
 
Event Description
Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, the patient experienced continuous glucose monitoring (cgm) inaccuracies and a hypoglycemic event. The sensor was inserted into the abdomen on (b)(6) 2017. Patient's father stated that at 3:00pm the dexcom receiver was displaying a message indicating that the patient had high blood glucose and did not display values. The patient's mother dosed the patient with bolus insulin. At the time, the patient was sleeping and their insulin pump was calculated at 5. 34, which was too high a dose, so patient's mother turned it down to 4. 9. At 3:30pm the patient woke up and was sluggish. The dexcom receiver showed the patient's bg was 61mg/dl, upon which the patient's mother tried to feed the patient but the patient refused. The patient began to cry, went limp and their eyes rolled back. The patient's mother called the paramedics who administered the patient glucose and transported them to the emergency room (er). The patient was admitted at 5:43pm and had blood and urine samples taken. The patient was released at 8:45pm the same day. At the time of contact, the patient was doing great. No additional event or patient information is available. Data was provided for evaluation. The reported issue of inaccurate cgm values was confirmed. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
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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 Key6411915
MDR Text Key70170528
Report Number3004753838-2017-23374
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 02/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2017
Device Model Number9500-27
Device Catalogue NumberSTS-GL-041
Device Lot Number5220618
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 Received03/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2016
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: 03/16/2017 Patient Sequence Number: 1
Treatment
OMNIPOD INSULIN PUMP
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