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

Model Number 71992-01

Device Problem Material Twisted/Bent (2981)

Patient Problems Hypoglycemia (1912); Nausea (1970); Loss of consciousness (2418); Diaphoresis (2452); Convulsion/Seizure (4406)

Event Date 07/31/2023

Event Type  Injury  

Event Description

A bent inserter needle was reported with the adc device and customer was therefore unable to monitor glucose levels.As a result, the customer experienced symptoms of hypoglycemia, nausea, cold, sweaty, seizure, and a loss of consciousness and was given an unspecified gel and injection as treatment by a healthcare professional due to the diagnosis of hypoglycemia.No further details were provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor kit expiration date is 31-may-2021.The medical event associated with this case occurred on (b)(6) 2023 which confirms the usage of the device beyond the useful life of the device.No additional investigation is required as the device met its specification lifespan.The device mfg 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.

• 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: 17600025
• MDR Text Key: 321710708
• Report Number: 2954323-2023-37017
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Type of Report: Initial
• Report Date: 08/22/2023

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 Expiration Date: 05/31/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention