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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE INC. GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 2) SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Low Readings (2460)
Patient Problem Hyperglycemia (1905)
Event Date 03/22/2021
Event Type  No Answer Provided  
Event Description
Patient was using freestyle libre 2 continuous glucose monitoring system. Patient reported his cgm readings were substantially lower than his fingerstick bg readings. Patient stated all the bg readings were taken prior to meals. Author verified sensor application technique and storage instructions with the patient. Patient denied any use of concomitant medications that may effect the cgm readings. Readings patient gave are as below: (b)(6) 2021 1230 pm: fingerstick 142, freestyle 74, (b)(6) 2021 530 pm: fingerstick 180, freestyle 136, (b)(6) 2021 breakfast reading 9: fingerstick 147 and freestyle was 60; (b)(6) 2021 noon reading: fingerstick 220 and freestyle 76, (b)(6) 2021 530 pm supper: fingerstick 125 and freestyle was 53, (b)(6) 2021 630pm: fingerstick 222, freestyle 147 patient was switched to dexcomg6 cgm. Dexcomcgm readings are as follows: (b)(6) 2021 615 pm, fingerstick: 156, dexcom 152, (b)(6) 2021 9 pm: fingerstick 243, dexcom240; (b)(6) 2021 breakfast: fingerstick 166, dexcom 145,(b)(6) 2021 lunchtime: fingerstick 128, dexcom 115, (b)(6) 2021 dinner: fingerstick208, dexcom 180, (b)(6) 2021 nighttime: fingerstick220, dexcom 171, (b)(6) 2021 breakfast: fingerstick 180, dexcom 158, (b)(6) 2021 lunchtime: fingerstick 189, dexcom 156, (b)(6) 2021 dinner: fingerstick 165, dexcom 141, (b)(6) 2021 nighttime: fingerstick 250, dexcom 158 (before insulin and not around eating); (b)(6) 2021: breakfast: fingerstick 125, dexcom 120, (b)(6) 2021: lunchtime: fingerstick 175, dexcom 151, (b)(6) 2021: dinner: fingerstick213, dexcom 179, (b)(6) 2021: nighttime: fingerstick257, dexcom 163 more of the dexcom readings appeared to be within the 20% range. Symptom: suspect drug# 1, dosing: use 1 sensor as directed every 14 days.
 
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Brand NameGLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 2)
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key11854970
MDR Text Key252154893
Report NumberMW5101445
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 04/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
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?
Type of Device Usage

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