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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM CONTINUOUS GLUCOSE MONITOR

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DEXCOM CONTINUOUS GLUCOSE MONITOR Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/12/2016
Event Type  Injury  
Event Description
Using a dexcom cgm for uncontrolled type 1 diabetes mellitus, the sensor wire detached and remained in the leg (upper thigh).
 
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Brand NameCONTINUOUS GLUCOSE MONITOR
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM
MDR Report Key5761343
MDR Text Key48642496
Report NumberMW5063166
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/27/2016 Patient Sequence Number: 1
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