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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE SENSOR SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

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ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE SENSOR SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Discomfort (2330); Sleep Dysfunction (2517); Lethargy (2560)
Event Date 06/12/2020
Event Type  No Answer Provided  
Event Description
Pt says one sensor was not measuring as high as it should, so she adjusted her blood glucose. Pt was uncomfortable sleeping a few nights because her blood glucose was 60 and didn't want to inject so she was very tired as a result. Pt reports approximate date of (b)(6) 2020 when this happened. Fda safety report id # (b)(4).
 
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Brand NameFREESTYLE LIBRE SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key10307512
MDR Text Key200214104
Report NumberMW5095646
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 Pharmacist
Type of Report Initial
Report Date 07/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/20/2020
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

Patient Treatment Data
Date Received: 07/21/2020 Patient Sequence Number: 1
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