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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE SENSORS SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Hyperglycemia (1905)
Event Date 10/06/2021
Event Type  Injury  
Event Description
Freestyle libre 2 sensor placed in clinic and readings are consistently hypoglycemic - when patient verifies with fingerstick, glucose is wnl. Patient denies sxs of hypoglycemia, but out of concern self-decrease his insulin significantly- now with frequent hyperglycemia. I had pt changed his sensor. Sensor reading inaccurately- false hypoglycemia. Glucose test (freestyle libre 2 (glucose) reader). Diagnosis for use: diabetes mellitus. Start date: (b)(6) 2021.
 
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Brand NameFREESTYLE LIBRE SENSORS
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key12672262
MDR Text Key277944413
Report NumberMW5104798
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 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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