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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAYS SENSOR SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAYS SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Dyspnea (1816); Overdose (1988)
Event Date 06/07/2019
Event Type  Injury  
Event Description
I placed a brand new freestyle libre sensor (14 days), friday morning 12:35 am, my husband wakes me because he noticed something weird with me and even the way i was breathing alerted him. He wakes me and tells me to check my sugar. I was really out of it. I decided to check my sugar with my omnipod pdm and it turns out it was at 29. The next day in the morning, i check with my freestyle sensor and it said 236, something, told me to check with pdm and i did and it turns out it was at 171. Seeing those results explained why i went so low the night before. I was using the sensor thinking and trusting the numbers were accurate but they weren't. I now use my pdm instead of the sensor since the sensor made me over bolus and almost not wake up the next day if it wasn't for my husband. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE 14 DAYS SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key8712450
MDR Text Key148793644
Report NumberMW5087457
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 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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: 06/18/2019 Patient Sequence Number: 1
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