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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM 6 SENSOR SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM 6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number STS OR 003
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 08/14/2022
Event Type  malfunction  
Event Description
I use the dexcom 6 sensor. I have been using it for 4 years. Since covid the failure rate has been at least one sensor per month or one out of 3 sensors. I am filing this complaint because i changed sensors yesterday. This morning at approximately 1:45 a. M. Cst my sensor failed and was reading 137 straight up (increasing), then 56 low. I had to finger stick to get the correct reading. I called dexcom and, as usual, they are sending a replacement. I need for these to be accurate. I can't have a false reading, administer insulin through my pump, and over dose. It is a real possibility and could case me significant harm. What can you do to ensure these sensors work accurately. Dexcom has no answers. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM 6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key15242519
MDR Text Key298250378
Report NumberMW5111528
Device Sequence Number1
Product Code MDS
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 08/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSTS OR 003
Device Lot Number7306133
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 08/16/2022 Patient Sequence Number: 1
Treatment
JARDIANCE; LOSARTAN ; NOVALOG; T-SLIM TANDEM PUMP; VASCEPA
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