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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC GUARDIAN SENSOR 3; SENSOR, GLUCOSE, INVASIVE
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MEDTRONIC MINIMED MEDTRONIC GUARDIAN SENSOR 3; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/12/2021
Event Type  malfunction  
Event Description
False low glucose readings; i am using a medtronic 670g insulin pump with a guardian 3 cgm.Over the past several weeks i have noticed the sensors are not meeting their full in use stability claim of 7 days.The last three sensors i used have lasted 5-6 days.Today my 5 day old sensor results suddenly dropped from approx 110 mg/do to 60 mg/dl.I tested my glucose with a finger stick and it showed a reading of 97.Previously in the day it gave a sensor updating message and requested a recalibration which failed.Later in the day i calibrated with a result of 110 and the pump read 90.I changed the sensor and it now appears to be accurate.This is the third sensor of this lot i've had trouble with and i've reported the first two issues to medtronic.Guardian sensor 3, sensor lot number hg5b8yu, exp 2022-05-17, red mat-7020a.Fda safety report id# (b)(4).
 
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Brand Name
MEDTRONIC GUARDIAN SENSOR 3
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key12475176
MDR Text Key271870140
Report NumberMW5103940
Device Sequence Number1
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 09/12/2021
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
Patient Weight87
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