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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM DEXCOM G5 CONTINUOUS GLUCOSE MONITOR

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DEXCOM DEXCOM G5 CONTINUOUS GLUCOSE MONITOR Back to Search Results
Device Problem Device Sensing Problem (2917)
Patient Problems Bone Fracture(s) (1870); Hypoglycemia (1912); Seizures (2063); Joint Dislocation (2374)
Event Type  Other  
Event Description
On (b)(6) 2016 glucose monitor stopped transferring signal to patient's phone. From 10pm-3am patient's blood sugar went low and patient went into a diabetic seizure which lasted about 6 minutes. During this time the patient dislocated his shoulder and broke his arm. Patient went to two different hospitals to get his shoulder back into socket. There is a likelihood that patient will need surgery.
 
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Brand NameDEXCOM G5 CONTINUOUS GLUCOSE MONITOR
Type of DeviceGLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM
MDR Report Key6112937
MDR Text Key60560033
Report NumberMW5066106
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
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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

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