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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Catalog Number STS-OR-001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Labeling indicates: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (e.G., redness, swelling, bruising, itching, scarring or skin discoloration).
 
Event Description
Dexcom was made aware on (b)(6)2021, that on (b)(6) 2021, the patient experienced a skin reaction. the sensor was inserted into the abdomen on (b)(6)2021.The patient stated itching, burning, rash, redness, inflammation, blisters, dry skin, and scar occurred.At the time of contact, it was indicated that the patient was stable.No additional event or patient information is available.
 
Manufacturer Narrative
(b)(4).H2- correction.H10- corrected data.3004753838 - 2021 - 86790 was reported in error.Please disregard initial reporting of this event as this event has now been deemed not reportable.
 
Event Description
Subsequent to the initial mdr, it was determined that a report was submitted in error.Upon further review, it was determined that the patient allegation does not meet the criteria of a reportable event.
 
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Brand Name
DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
MDR Report Key11822746
MDR Text Key250725192
Report Number3004753838-2021-86790
Device Sequence Number1
Product Code QDK
Combination Product (y/n)N
PMA/PMN Number
DEN170088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberSTS-OR-001
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/13/2021
Initial Date FDA Received05/13/2021
Supplement Dates Manufacturer Received09/03/2021
Supplement Dates FDA Received09/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age56 YR
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