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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
Event Date 10/06/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).Diabetes mellitus is a known cause of diabetic ketoacidosis.
 
Event Description
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient was hospitalized for diabetic ketoacidosis.At the time of the event, the patient was wearing the continuous glucose monitor (cgm) and they were alerted by the cgm system.There was no alleged device malfunction.Additional event or patient is not available.No product or data was returned for evaluation.The reported event could not be confirmed.A root cause could not be determined.
 
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Brand Name
NI
Type of Device
CONTINUOUS 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 Key6068440
MDR Text Key58814358
Report Number3004753838-2016-80774
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 health professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/06/2016
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/06/2016
Initial Date FDA Received10/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
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