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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-PNK
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Seizures (2063); Vomiting (2144); Concussion (2192)
Event Date 11/06/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and its associated effects.
 
Event Description
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced err121 and a hypoglycemic event. Patient's mother reported that due to the receiver displaying the error icon, they were unable to get values and the patient had an urgent low. Patient was taken to the emergency room and was vomiting, had a seizure and a concussion due to a low blood glucose value of 30mg/dl. The patient was given ibuprofen and zofran. Patient was released from the hospital the same day. At the time of contact, the patient was doing well. Additional event or patient information is not available. No product or data was returned for evaluation. The reported event of error icon displayed 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 Key6136119
MDR Text Key61149512
Report Number3004753838-2016-52774
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 11/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22719-PNK
Device Catalogue NumberSTK-GF-PNK
Device Lot Number5214663
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 Received11/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/30/2016 Patient Sequence Number: 1
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