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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 Problems No Audible Alarm (1019); Use of Device Problem (1670)
Patient Problem Seizures (2063)
Event Date 09/18/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of seizures.
 
Event Description
Dexcom was made aware on (b)(6) 2016 that on (b)(6) 2016, the patient experienced no audio alert from the receiver and an adverse event. Patient's mother reported that patient experienced a seizure in her kitchen due to the audio alert not sounding. The patient's mother called 911. Patient was taken to the emergency room (er). Patient's mother reported patient having blood work and a computerized tomography (ct) scan, but no treatment was given. No additional event or patient information is available. No product was provided for evaluation. Data was received for evaluation. However, an evaluation cannot be performed to confirm the reported issue. A root cause could not be determined. The sensor was inserted into the arm. The dexcom g5 mobile continuous glucose monitoring system states: do not insert the sensor component of the dexcom g5 mobile system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). The placement and insertion of the sensor component of the dexcom g5 mobile system is not approved for other sites. If placed in other areas, the dexcom g5 mobile system may not function properly.
 
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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 Key6018696
MDR Text Key57045595
Report Number3004753838-2016-84236
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
Report Date 09/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2016
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 Number5213127
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 Received09/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2015
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: 10/11/2016 Patient Sequence Number: 1
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