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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. UNKNOWN MDS

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DEXCOM, INC. UNKNOWN MDS Back to Search Results
Model Number 9500-27
Device Problem Invalid Sensing (2293)
Patient Problem Seizures (2063)
Event Date 05/23/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of seizures.
 
Event Description
Patient's mother contacted dexcom on (b)(6) 2016 to report that the patient experienced continuous glucose monitoring (cgm) inaccuracies and an adverse event on (b)(6) 2016. The date of the event is an approximation. Patient's mother reported the patient had a seizure while sleeping at her home. Patient's mother checked patient's receiver and the patient's blood glucose (bg) was 150 points different from his glucometer. Patient's mother stated that he apparently had not calibrated the device like he needed to. Patient's mother stated that she worked with him and was able to bring the devices closer to accuracy. Patient's mother stated that the patient suffered from low blood sugar seizures, and most likely had 500 plus seizures over his life span mostly as a young adult. No additional patient or event information was provided.
 
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Brand NameUNKNOWN
Type of DeviceMDS
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 Key5766678
MDR Text Key48711268
Report Number3004753838-2016-13074
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 06/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/01/2016 Patient Sequence Number: 1
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