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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 PN 9500-45
Device Problems Patient-Device Incompatibility (2682); Device Markings/Labelling Problem (2911)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 11/01/2021
Event Type  malfunction  
Event Description
Allergic reaction; i have a type 1 latex allergy and type 1 diabetes. I have been using a dexcom g6 cgm for 3 years. Sometime in 2020, i started having allergic reactions to the sensor adhesive. These have been getting worse despite preapplication treatment with topical steroid. I called dexcom to report the problem and was told that they had changed the adhesive on the sensor. I suspect that the new adhesive contains latex, even though it is not labeled that way. It is not labeled as being latex-free. Data from the most recently removed sensor: (b)(6). 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 Key12751090
MDR Text Key280511456
Report NumberMW5105122
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 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2022
Device Model NumberPN 9500-45
Device Lot Number7290468
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 11/03/2021 Patient Sequence Number: 1
Treatment
ALLEGRA; APIDRA INSULIN; BENICAR; BROMINIDINE EYE DROPS ; BYSTOLIC; HCTZ; LIVALO; MELATONIN 5MG PRN INSOMNIA; QNASL; QVAR; SINGULAIR; TRESIBA INSULIN; TRIAMCINOLONE ACETONIDE LOTION 0.1% APPLIED TO SENSOR SITE BEFORE AND AFTER SENSOR APPLICATION; TYLENOL PRN PAIN
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