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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
Lot Number 5279747AND7299088 (SEE ABOVE)
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Expiration Date Error (2528); Device Markings/Labelling Problem (2911)
Patient Problem Hypoglycemia (1912)
Event Type  malfunction  
Event Description
Low blood sugar. I have reported this problem on many occasions to dexcom. The manufacturer, not the diabetes supplier, is repackaging expired sensors in new boxes and shipping them to government customers. I reported this to the oig as well in december when this last occurred. Today i opened the box to insert a new sensor. The label on the box had a lot number of 7299088 with an expiration date of 3-13-2022. The package on the inside where the sensor is had a lot number of 5279747 with an expiration date of 9-14-2021. This came to me directly from the manufacturer as i have complained about this exact same thing on at least three other occasions. As a general rule, these expired sensors are very inaccurate with incorrect readings, despite calibration. No one seems to care. As i said, i contacted medicare who said they couldn't do anything about it because its contract is with the diabetes supplies and not dexcom. This is not a diabetes supplier problem as these replacement sensors are shipped from dexcom directly. I was referred to the office of the inspector general. I filed a complaint on this same thing with oig. And still, i am getting replacement sensors that have expired and cannot be calibrated. 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 Key13358906
MDR Text Key284623906
Report NumberMW5106995
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 01/23/2022
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received01/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number5279747AND7299088 (SEE ABOVE)
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 01/25/2022 Patient Sequence Number: 1
Treatment
INSULIN; JARDIANCE; LEVOTHYROXINE; METFORMIN
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