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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
Catalog Number SW10611
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Seizures (2063)
Event Date 02/16/2017
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, the g5 mobile application had intermittent audio output and patient experienced an adverse event. Patient's wife reported that the patient did not hear the low alert. Patient was found having seizures and a blood glucose (bg) of 30 mg/dl. A 911 call was made. Emergency medical technicians (emts) arrived and treated patient with 15 grams of glucose. At time of contact, patient is stable. No additional event or patient information was provided. Data was provided for evaluation. Patient entered a calibration at 04:25am utc. The calibration was not accepted as did not meet the minimum value requirement of >40 mg/dl. Patient had entered 33 mg/dl g5 mobile application responded with a displayed message prompting to enter another bg value. A calibration was successfully entered at 07:35am utc upon which the patient's g5 mobile application displayed a value and audibly gave a low alert. It is between the time of 04:25am utc and 07:35am utc that the patient alleges the adverse event took place, during this time no alert was given for the low glucose due to the g5 mobile application not displaying any values during its request for an additional calibration. The reported no audio alert was confirmed via data. The root cause was determined to be patient misuse/error.
 
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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 Key6411864
MDR Text Key70170349
Report Number3004753838-2017-15989
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000002
UDI-Public(01)00386270000002
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 02/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSW10611
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 Received02/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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