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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED GUARDIAN SENSOR 3 SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED GUARDIAN SENSOR 3 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Seizures (2063); Loss of consciousness (2418)
Event Date 09/30/2019
Event Type  malfunction  
Event Description
Sensor failure of the guardian continuous glucose monitoring sensor for the medtronic 670g insulin pump. The glucose readings show either low and the actual blood glucose reading via fingerstick is high, or vice versa. This has happened dozens of times. It is worn in my abdomen. This product does not accurately read blood glucose levels which effects the amount of insulin that the pump delivers. It checks the blood glucose every 5 mins which determines the amount of insulin administered through the pump. I have reported this dozens of times to medtronic with absolutely no explanation except they will replace that sensor and want the failed one returned to them. Blood glucose read 116 on the pump (via sensor) and my actual blood sugar was 301. On (b)(6) 2019 my blood sugar was 17 and the pump was showing my blood sugar as 96. This caused a seizure and the use of an emergency glucagon injection (hypo-kit) administered by my husband to make me conscious again. This has been occurring since (b)(6) 2019 and it does not matter the lot number or expirate date, they are different with each box of sensors. Medtronic did change out my transmitter for the sensor to the latest version back in (b)(6) which is when these problems started. Medtronic tells me this is unrelated but i was not having these problems with the previous transmitter for the sensor prior to (b)(6).
 
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Brand NameGUARDIAN SENSOR 3
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key9172469
MDR Text Key161845653
Report NumberMW5090292
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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

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