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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number 9500-45
Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2022
Event Type  Injury  
Event Description
There have been numerous occasions where the dexcom g6 sensor has failed entirely or given grossly ineffective readings. I have repeatedly reached out to the manufacturer but without substantive results. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key14756441
MDR Text Key294506787
Report NumberMW5110397
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000255
UDI-Public(01)00386270000255
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-45
Device Lot Number7289552
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 06/17/2022 Patient Sequence Number: 1
Treatment
MULTI-VITAMIN
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