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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Hypoglycemia (1912); Overdose (1988)
Event Date 02/01/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient contacted dexcom on (b)(6) 2016, to report that the paramedics were called on (b)(6) 2016. Patient was not wearing dexcom continuous glucose monitor (cgm) at the time of the reported event. Patient was waiting for a shipment and it was taking some time with insurance. Patient reported that during this period, he experienced a low event of 42 mg/dl. Patient's wife called the paramedics. Patient was not transported to the hospital. Patient was fine after a bit of time. Patient reported that he had taken an extra unit of insulin prior to the reported event. At the time of contact, patient reported current condition as "good". No additional event or patient information is available. There was no alleged malfunction against the device. The complaint states that the patient experienced a low event on (b)(6) 2016. It should be noted that diabetes mellitus is a known cause of low blood glucose levels.
 
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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 Key5468473
MDR Text Key39325704
Report Number3004753838-2016-01353
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 02/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2016
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 Received02/02/2016
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: 02/29/2016 Patient Sequence Number: 1
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