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

Model Number 71733-01

Device Problem Device Alarm System (1012)

Patient Problems Hypoglycemia (1912); Diaphoresis (2452)

Event Date 02/24/2024

Event Type  Injury  

Event Description

An alarm issue was reported with the abbott diabetes care (adc) device in use with iphone with ios operating system 16 and with software version 2.7.5.4.061.A customer reported their adc device failed to sound when their glucose was low and as a result, the customer experienced symptoms described as "could not get up" and sweating.The customer's daughter treated them with orange juice and no further information was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The most probable root causes associated with this failure mode are software/data corruption or misuse.However, mitigations are in place to reduce and prevent such issues.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The customer experienced missing low glucose alarms with freestyle libre 2 application.Adc attempted to replicate the reported issue using similar configuration of iphone with ios operating system version 16.The reported issue was unable to be replicated and the system functioned as intended.There were no issue identified with the freestyle libre 2 app during replication that would have led to the reported issue.The device manufacturing date does not apply.The date entered in section h4 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: 18965551
• MDR Text Key: 338428965
• Report Number: 2954323-2024-09832
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599000059
• UDI-Public: 00357599000059
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71733-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention