MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

Device Problem High Readings (2459)

Patient Problems Hypoglycemia (1912); Blurred Vision (2137); Hot Flashes/Flushes (2153); Shaking/Tremors (2515)

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

The customer reported a high readings issue with the adc freestyle libre sensor.The customer reported self-treating with insulin based on the sensor scan reading, and subsequently experienced symptoms of shaking, vision issues, and "felt cold and then warm".The customer had contact with a healthcare professional, where a healthcare meter reading of 49 mg/dl was obtained.The customer was diagnosed with hypoglycemia and treated with glucose via iv.Comparison readings taken after treatment were as follows: 92 mg/dl, 97 mg/dl, and 132 mg/dl on the healthcare meter, compared to 245 mg/dl, 278 mg/dl, and 386 mg/dl from the sensor.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.

Event Description

The customer reported a high readings issue with the adc freestyle libre sensor.The customer reported self-treating with insulin based on the sensor scan reading, and subsequently experienced symptoms of shaking, vision issues, and "felt cold and then warm".The customer had contact with a healthcare professional, where a healthcare meter reading of 49 mg/dl was obtained.The customer was diagnosed with hypoglycemia and treated with glucose via iv.Comparison readings taken after treatment were as follows: 92 mg/dl, 97 mg/dl, and 132 mg/dl on the healthcare meter, compared to 245 mg/dl, 278 mg/dl, and 386 mg/dl from the sensor.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: tara williamson ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644472
• MDR Report Key: 9819002
• MDR Text Key: 183133660
• Report Number: 2954323-2020-01996
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

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: 71940-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• 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): Required Intervention