MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE PRO; BLOOD GLUCOSE MONITORING SYSTEM

Model Number 71562-01

Device Problem Low Readings (2460)

Patient Problems Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 11/25/2018

Event Type  Injury  

Manufacturer Narrative

The reported product is not expected to be returned.A follow-up report will be filed if product is returned or additional information is obtained.The device mfg date is unknown.It should be noted that the adc freestyle libre pro device is not marketed directly to customer.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Caller, customer's mother, reported the customer consistently received a scan result of 50 mg/dl while wearing an adc freestyle libre pro sensor.It was further reported this result was "60 to 70% different" when compared to an unspecified reading obtained on a competitor brand meter.Customer experienced symptoms described as vomiting and stomach pain, and was "rushed to the hospital" where a reading of 450 mg/dl was obtained on an hcp meter.Customer was diagnosed with diabetic ketoacidosis (dka), admitted to the hospital, and treated with an unspecified "high dose of insulin".The customer was released from the hospital on (b)(6) 2018.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE PRO
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 8182658
• MDR Text Key: 130973606
• Report Number: 2954323-2018-09746
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P150021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 12/19/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71562-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 20 YR