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 Hyperglycemia (1905); Loss of consciousness (2418); Convulsion/Seizure (4406); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

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.Dhrs (device history record) 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 customer reported an unspecified high reading issue with the freestyle libre 2 sensor, as compared to capillary result.The customer experienced cramps, seizure, and loss of consciousness, and required help by wife to issue insulin from pump.High readings with sensor are generally indicative of hyperglycemia and consistent with reported treatment of insulin; however, as customer did not provide associated readings, it is unknown if customer's reported high reading indicated hyperglycemia at time of event.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported an unspecified high reading issue with the freestyle libre 2 sensor, as compared to capillary result.The customer experienced cramps, seizure, and loss of consciousness, and required help by wife to issue insulin from pump.High readings with sensor are generally indicative of hyperglycemia and consistent with reported treatment of insulin; however, as customer did not provide associated readings, it is unknown if customer's reported high reading indicated hyperglycemia at time of event.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform linearity testing while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.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
• MDR Report Key: 11373714
• MDR Text Key: 233337429
• Report Number: 2954323-2021-05057
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

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: 03/31/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 72