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U.S. Department of Health and Human Services

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

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DEXCOM, INC. CONTINUOUS GLUCOSE MONITOR Back to Search Results
Catalog Number UNKNOWN
Device Problem Imprecision (1307)
Patient Problem Diabetic Ketoacidosis (2364)
Event Date 11/25/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of diabetic ketoacidosis.
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter. The sensor was inserted into the abdomen. The patient's doctor stated the patient was brought to the emergency room (er) by a family member, presented with diabetic ketoacidosis and was admitted. The doctor indicated that the dexcom was 500 points off at the time of event. It is unknown of how long the patient was hospitalized; however, the patient's doctor stated they were discharged in stable condition and at their last check in with the patient, they were doing okay. No data was provided for evaluation. The complaint confirmation and root cause could not be determined. No additional event or patient information is available.
 
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Brand NameNI
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key8189279
MDR Text Key131150741
Report Number3004753838-2018-160757
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 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/21/2018 Patient Sequence Number: 1
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