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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 Device Markings/Labelling Problem (2911); Packaging Problem (3007)
Patient Problem Insufficient Information (4580)
Event Date 12/29/2021
Event Type  malfunction  
Event Description
On wednesday, (b)(6) 2021, i opened a box containing a single dexcom g6 sensor. The product inside was expired (exp. 9-10-2021 lot# 7279769). The box it came in was labelled completely differently (exp. 9-03-2022 lot# 7298986). The box was a replacement single dexcom g6 sensor box that i received directly from dexcom. I called dexcom to inform them of the issue. The representative mentioned that they sometimes test expired products and if it meets certain conditions, they give it an extended expiration and then send them out. The representative also said that he will be sending me two replacement sensors and to throw away the expired one which i was calling about. I did not throw it away; i still have the product if you need to see it. Even if it is true that the product may have met certain conditions, why repackage that product with different information and lot number? from what i understand this is a misbranding issue and potentially illegal. 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 Key13177508
MDR Text Key283486769
Report NumberMW5106493
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 01/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date09/10/2021
Device Model Number9500-45
Device Lot Number7279769
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 01/05/2022 Patient Sequence Number: 1
Treatment
ATORVASTATIN ; COQ-10; DEXCOM G6 SYSTEM; LEVEMIR FLEXTOUCH; LISINOPRIL ; MULTIVITAMIN ; NOVOLOG FLEXPEN; SOTALOL; VITAMIN D ; XARELTO ; ZINC
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