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

Device Problem Incorrect, Inadequate or Imprecise Result or 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).

• Brand Name: FREESTYLE LIBRE 10 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT LABORATORIES / ABBOTT DIABETES CARE INC.
• MDR Report Key: 8500538
• MDR Text Key: 141731217
• Report Number: MW5085735
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 18 YR
• Patient Weight: 66