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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 MT22719-BLU
Device Problem Defective Alarm (1014)
Patient Problem Seizures (2063)
Event Date 03/04/2017
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 patient experienced an intermittent audio alert and an adverse event. Patient's mother reported patient had a seizure and bit their tongue. Patient's mother drove the patient to an emergency room (er). Patient was observed for four (4) hours in the er. No medication was administered. Patient's mother alleges that not hearing alarms contributed to the event. Additionally, the patient tested the alert function of the receiver and the audio alert did work. At time of contact, patient is okay. No additional event or patient information is available. No product or data was provided for investigation. The reported event could not be confirmed. The root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint device was returned for evaluation. The device was visually inspected and no defect was found. Functional testing was performed and the reported fault could not be reproduced and there was no failure detected. A review of the downloaded receiver log did not find any errors related to the customer complaint. A manual drop test for intermittency was performed and the test passed. The reported event of an intermittent audio output was not confirmed. A root cause could not be determined.
 
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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 Key6438826
MDR Text Key70999913
Report Number3004753838-2017-23445
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22719-BLU
Device Catalogue NumberSTR-GF-BLU
Device Lot Number5220969
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/27/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number3004753838-02/29/16-001C

Patient Treatment Data
Date Received: 03/28/2017 Patient Sequence Number: 1
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