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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. MDS

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DEXCOM, INC. MDS Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Hypoglycemia (1912)
Event Date 02/05/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient's mother contacted dexcom on (b)(6) 2016, to report a patient hospitalization that occurred on approximately (b)(6) 2016. The patient and the patient's mother do not know the exact date of hospitalization but believe that the patient's boyfriend took the patient to the hospital. It was reported that the patient was hospitalized for diabetic low complications. Patient was wearing dexcom continuous glucose monitor (cgm) at the time of the reported event. Patient reported that cgm alerted her of the low blood glucose (bg) level. Patient went to the store to get juice and does not remember what happened after that. Patient reported that the diabetic low event was followed by cardiac arrest. Medical tests were performed discovering that the patient also had a blood clot in the right leg. Patient reported that the blood clot in the right leg resulted in amputation of the right leg. Patient reported that the insulin pump had given her too much insulin. Patient reported that dexcom cgm was functioning properly and that the reported event was not related to dexcom use. At the time of contact, the patient was still hospitalized at a rehabilitation facility for therapy. No additional event or patient information is available. There was no alleged malfunction against the device. The complaint states that the patient experienced diabetic low complications. It should be noted that diabetes mellitus is a known cause of low blood glucose and other complications of the disease.
 
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Brand NameNI
Type of DeviceMDS
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego 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 Key5474759
MDR Text Key39505216
Report Number3004753838-2016-01411
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 02/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2016
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 Received02/05/2016
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: 03/02/2016 Patient Sequence Number: 1
Treatment
INSULIN PUMP
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