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U.S. Department of Health and Human Services

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

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MEDTRONIC MINIMED GUARDIAN SENSOR CGM SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT_7020A
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Defective Component (2292)
Patient Problem Hypoglycemia (1912)
Event Date 01/15/2020
Event Type  Injury  
Event Description
My wife is on medtronic's insulin pump minimed 670g smart guard with guardian sensor. We often rely on the reading of the sensor on how much an insulin dose is given. However we found out that the reading of the sensor on the pump versus the reading of the finger stick is too wide. Sometimes ranging from 70-100 mg/dl. Luckily the pump is not on auto mode. Sometimes my wife will just depend on the sensor reading and take some glucose pill if the reading is 70. Sometimes the sensor will not last for 7 days as advertised. Medtronic, however, is very nice in replacing defective sensors immediately free of charge. We follow their instruction very well. Change the infusion site; change the newly inserted sensor, questioning the use of tylenol, etc. Our endocrinologist has some reservation on the use of these medtronic products now and suggested that sometimes in the future we should switch to another insulin pump. Reason, the hgb a1c of my wife is always above 8. 7, in spite of numerous adjustments of the minimed 670g pump by our endocrinologist. I don't have now the data from regular labs but i could remember there was a discrepancy on two results from the quest lab and the minimed 670g pump with cgm. Fda safety report id# (b)(4).
 
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Brand NameGUARDIAN SENSOR CGM
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key9728899
MDR Text Key180362392
Report NumberMW5093077
Device Sequence Number2
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
Type of Report Initial
Report Date 02/13/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT_7020A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/18/2020 Patient Sequence Number: 1
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