MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71992-01

Device Problem High Readings (2459)

Patient Problems Hypoglycemia (1912); Chills (2191); Diaphoresis (2452); Confusion/ Disorientation (2553); Convulsion/Seizure (4406)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

Adc investigated this issue and determined that the libre 2 sensor associated with this complaint did not meet product design specifications and may produce high glucose readings which are not clinically acceptable.Based on the results of this investigation, this complaint is confirmed.This issue was addressed in the field by adc fa1004-2023.If the product is returned an investigation will be conducted and a follow up submitted.The device manufacturing date is unknown.The date entered in the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported receiving high glucose results from an abbott diabetes care device.A high reading issue was reported with the abbott diabetes care (adc) device.A customer reported receiving a high scan of 18 mmol/l on the sensor when compared to a competitor meter result of 4 mmol/l.The customer further reported that they self-treated with ¿too much insulin¿ and as a result, experienced cold sweats, disorientation, and seizures from (b)(6) 2023 to (b)(6) 2023.The customer had contact with a healthcare professional on (b)(6) 2023 and glucose was administered for the diagnosis of hypoglycemia.No further information was provided.This is a known issue for the serial number associated with this complaint, addressed by adc fa1004-2023 and a report is therefore being submitted.The impacted product associated with this complaint has not been distributed in the usa.Impacted product was distributed to canada, japan, saudi arabia, and united kingdom.Adc field action fa1004-2023 was issued only to impacted countries.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16440818
• MDR Text Key: 310226741
• Report Number: 2954323-2023-08085
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: QUALITY RECORD QR864898
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention