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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 Death (1802); Pneumonia (2011); Renal Failure (2041)
Event Date 01/22/2016
Event Type  Death  
Manufacturer Narrative
(b)(4) diabetes mellitus is a known cause of death.
 
Event Description
Patient's husband contacted dexcom on (b)(6) 2016 to report that the patient passed away. Patient's husband stated that on (b)(6) 2016 the patient was taken to the hospital via ambulance. Patient was transferred to another hospital at her husband's request, where the patient spent the next four days. At that time, the patient's kidneys were no longer functioning and her lungs developed pneumonia. Patient was taken off life-support and passed on (b)(6) 2016. A cause of death was not reported. A certificate of death was not provided. The patient was not using the continuous glucose monitoring device at the time of passing, as the painkillers she took for back pain affected the system. There was no alleged device malfunction. No additional event or patient information was provided.
 
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Brand NameNI
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 Key5590847
MDR Text Key43095241
Report Number3004753838-2016-02376
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 other
Reporter Occupation
Type of Report Initial
Report Date 03/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2016
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 Received03/21/2016
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

Patient Treatment Data
Date Received: 04/20/2016 Patient Sequence Number: 1
Treatment
SINAPRYL
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