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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 Problem Seizures (2063)
Event Date 04/16/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The g5 system is associated with product code pqf.
 
Event Description
Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, that the patient experienced continuous glucose monitoring (cgm) inaccuracies and a seizure. The sensor was inserted at the abdomen on (b)(6) 2017. At 3:00 am, patient confirmed her cgm blood glucose (bg) value at 159 mg/dl. Patient confirmed cgm bg at 6:15 am had a value of 99 mg/dl. Patient checked her finger stick (fs) value and it was 47 mg/dl, and she had a seizure. Patient reported convulsing and her mouth was foaming. Patient was treated for seizure with a glucose pen by her husband. Patient did not go to hospital. At the time of contact, patient is good. No additional patient or event information was provided. Data was provided for evaluation. The reported cgm inaccuracies was confirmed via data. The root cause could not be determined. The patient did not enter the bg meter values into the cgm device accurately. Labeling indicates: entering the wrong bg values, or waiting more than five minutes before entry, might affect sensor performance, resulting in you missing a severe low or high event.
 
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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 Key6565099
MDR Text Key75087770
Report Number3004753838-2017-26432
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 04/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2017
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 Received04/17/2017
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: 05/12/2017 Patient Sequence Number: 1
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