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U.S. Department of Health and Human Services

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

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MEDTRONIC MINIMED GUARDIAN SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number HG4ON3T
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Device Displays Incorrect Message (2591); Calibration Problem (2890); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330)
Event Date 11/14/2019
Event Type  malfunction  
Event Description
Reporter advised he is frustrated and discouraged with his device. He alleges that for the past four months the sensors have not been functioning properly. He has experienced errors, calibration issues, false and out of range results. He does not feel safe using the device and they don't last for 7 days as specified by the mfr. Reporter advised this caused him to change sensors frequently causing bleeding and discomfort. He has reported to the mfr and he believes the fda needs to investigate the device. He believes there is a product quality problem and thinks the sensors and possibly the transmitter are out of spec.
 
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Brand NameGUARDIAN SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key9720713
MDR Text Key180043530
Report NumberMW5093025
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 Patient
Type of Report Initial
Report Date 02/14/2020
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received02/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberHG4ON3T
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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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