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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM INC. DEXCOM G6 SENSORS SENSOR, GLUCOSE, INVASIVE

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DEXCOM INC. DEXCOM G6 SENSORS SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number DEXCOM G6
Device Problems Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535); Ambient Temperature Problem (2878); Device Sensing Problem (2917)
Patient Problem Hyperglycemia (1905)
Event Date 01/03/2021
Event Type  Injury  
Event Description
On (b)(6) 2021; automatic refill was sent without my consent or order. Refill package was left on my porch, and left over the new years holiday, sent by byram healthcare, without any insulation to ensure sensors remained within dexcom's stated safe temperature range (36f-80f). On (b)(6) 2021, i initiated a sensor session with a sensor from the box that had been left out in the cold. Throughout the day yesterday, (b)(6) 2021, i repeatedly encountered no-readings alerts as well as sensor errors (upper 300s). As i knew that my sensors' safety may have been compromised, and because my readings were so high, i ended my sensor session early and selected a sensor that i knew had been stored properly, and i proceeded with a different session. I did complete a tech support report for dexcom (b)(4). Erratic readings with sensors included in shipment. Quantity 9 sensors. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 SENSORS
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM INC.
MDR Report Key11321459
MDR Text Key232183376
Report NumberMW5099359
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/09/2021
9 Devices were Involved in the Event: 1   2   3   4   5   6   7   8   9  
1 Patient was Involved in the Event
Date FDA Received02/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDEXCOM G6
Device Lot NumberSEE UPLOADED IMAGE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/11/2021 Patient Sequence Number: 1
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