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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. UNKNOWN CONTINUOUS GLUCOSE MONITOR

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DEXCOM, INC. UNKNOWN CONTINUOUS GLUCOSE MONITOR Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seizures (2063)
Event Date 11/23/2016
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, that the patient experienced a diabetic seizure. A family member alleged that the seizure was due to the monitor being off line for five (5) hours. It is not known what treatment was provided to patient. No additional patient or event information was provided. No product or data was provided for investigation. The reported issue could not be confirmed. The root cause could not be determined.
 
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Brand NameUNKNOWN
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 Key6599013
MDR Text Key76218388
Report Number3004753838-2017-44544
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
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 11/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
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 Received11/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/30/2017 Patient Sequence Number: 1
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