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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC GUARDIAN 3 SENSOR; SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC, INC. MEDTRONIC GUARDIAN 3 SENSOR; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 5062556-085_A
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
Event Date 05/02/2019
Event Type  malfunction  
Event Description
Devices used: medtronic 670g insulin pump, medtronic contour next link 24 glucometer, guardian sensor 3.At 9:15am, student came to health office c/o stomach ache.Sensor bs was 275.Due to symptoms, a finger stick blood sugar was checked (bs).Glucometer bs was 426.Urine ketones were large.Had a finger stick bs not been checked, and we solely relied on the result of the sensor, the student's hyperglycemia would not have been treated properly.This is a potential safety issue with the guardian sensor.The sensor appeared in place and not due to be changed for 3 days.Fda safety report id# (b)(4).
 
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Brand Name
MEDTRONIC GUARDIAN 3 SENSOR
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC, INC.
fridley MN
MDR Report Key8591148
MDR Text Key144674448
Report NumberMW5086448
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot Number5062556-085_A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age9 YR
Patient Weight25
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