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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 GLUCOSE MONITOR SENSOR SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 GLUCOSE MONITOR SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number FREESTYLE LIBRE 2 GLUCOSE MONITO
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Insufficient Information (4580)
Event Date 02/10/2021
Event Type  No Answer Provided  
Event Description
Patient wore his freestyle libre 2 glucose monitor sensor into the mri scan room and was scanned with it on. Reviewed records of type of implant and researched mri safety conditions. At this time is marked unsafe due to no testing being performed on the sensor. The company advises to remove for mri, ct, and x-ray prior to imaging. Followed up with physician and patient and the device had no malfunction. Monitoring results were reviewed with patient on (b)(6) 2021 and there was no malfunction or disruption. At that time, the sensor was removed and replaced with a new sensor per protocol. Fda safety report id # (b)(4).
 
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Brand NameFREESTYLE LIBRE 2 GLUCOSE MONITOR SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key11358084
MDR Text Key233266089
Report NumberMW5099525
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 02/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/15/2021
Device Model NumberFREESTYLE LIBRE 2 GLUCOSE MONITO
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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