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

Model Number 71992-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems Dehydration (1807); Headache (1880); Hyperglycemia (1905); Blurred Vision (2137); Dizziness (2194); Diaphoresis (2452); Shaking/Tremors (2515)

Event Date 05/10/2023

Event Type  Injury  

Event Description

A scan again in 10 minutes error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced symptoms described as "dry eyes (could not see), dizziness, headache, thirst, sweats, tremors, and blurred vision.The customer was provided juice and glucose by their spouse for treatment and then had contact with a healthcare professional, who obtained a glucose reading of 243 mg/dl.The customer was diagnosed with hyperglycemia and insulin (type/dose unknown) was taken for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle 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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A scan again in 10 minutes error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced symptoms described as "dry eyes (could not see), dizziness, headache, thirst, sweats, tremors, and blurred vision.The customer was provided juice and glucose by their spouse for treatment and then had contact with a healthcare professional, who obtained a glucose reading of 243 mg/dl.The customer was diagnosed with hyperglycemia and insulin (type/dose unknown) was taken for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The reported sensor (b)(6) has been returned and investigated.Sensor plug is properly seated in the mount and no physical damage is observed on the sensor patch.Sensor was found to be in state 6 (indicating abnormal termination) with a brownout reset event internally logged (event 21).No failure modes were observed with the sensor plug upon visual inspection.The returned sensor was sent for further investigation and de-cased.No issues were observed upon visual inspection of the pcba (sensor¿s printed circuit board assembly).The battery was measured and was found to be within specification.Therefore, this issue is confirmed to brown out reset.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: 17001781
• MDR Text Key: 315920821
• Report Number: 2954323-2023-21659
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 07/17/2023

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: 04/30/2024
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 07/16/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• 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