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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES / ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 10 DAY SENSOR, GLUCOSE, INVASIVE

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ABBOTT LABORATORIES / ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 10 DAY SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Hyperglycemia (1905); Nausea (1970); Tachycardia (2095); Vomiting (2144); Diabetic Ketoacidosis (2364)
Event Date 03/31/2019
Event Type  Injury  
Event Description
Pt (my (b)(6) daughter) has type 1 diabetes. She uses the abbott freestyle libre 10 day to monitor her glucose displayed on her iphone when she scans the phone against the device. She was feeling ill with unusual symptoms. The reader indicated a reading of 289 mg/dl. Due to symptoms of shallow, rapid beating, rapid heart rate and nausea, she tested blood glucose with her contour next link and her bg was 600+ mg/dl. She then administered her humalog insulin as the dr has prescribed in situation like this. Next, she tested ketones with urine test which results were "large". She then vomited. I advised her to go to the emergency room to be further evaluated and receive proper fluids. While in the er (for about an hour and a half), she was diagnosed to be in dka (diabetic ketoacidosis). She was admitted to the icu and was provided treatment for about 24 hours until she was out of dka. They held her for about an add'l 18 hours in the icu until she was completely stabilized before transferring her to regular inpatient care where she remained for about 3 hours. (b)(4).
 
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Brand NameFREESTYLE LIBRE 10 DAY
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT LABORATORIES / ABBOTT DIABETES CARE INC.
MDR Report Key8500538
MDR Text Key141731217
Report NumberMW5085735
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 Family Member or Friend
Type of Report Initial
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2019
Is this an Adverse Event Report? Yes
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/09/2019 Patient Sequence Number: 1
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