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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM INC. SENSOR; SENSOR, GLUCOSE, INVASIVE
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DEXCOM INC. SENSOR; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Catalog Number 9500-45
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Hypoglycemia (1912)
Event Date 08/05/2021
Event Type  Injury  
Event Description
Dexcom g6 sensor producing false and incorrect readings putting patient life at risk.Patient has replaced sensor four times in the last week.Company has been contacted with no satisfactory results.Keep replacing sensor but to no avail.Have tried different lot numbers with adverse glucose readings.When sensor reading is compared to finger stick reading there is a discrepancy > 20%.The following number has been called several times, (b)(6).Only solution has been a new sensor; however, reliability issues continued threatening patient's life.Called on monday (b)(6), sensor replaced lot number 7290435/ pn 9500-45, # 5937 additional faulty sensor tag # 5931, transmitter 9445-24 / sn (b)(4) activated on (b)(6) 2021.This malfunction translated into incorrect/adverse insulin adjustment and excessive carbohydrate intake precipitated by low glucose readings and corresponding false repetitive alarms.Fda safety report id # (b)(4).
 
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Brand Name
SENSOR
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM INC.
MDR Report Key12324905
MDR Text Key267042863
Report NumberMW5103250
Device Sequence Number2
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/11/2021
5 Devices were Involved in the Event: 1   2   3   4   5  
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number9500-45
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age66 YR
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