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

Model Number 71953-01

Device Problem Power Problem (3010)

Patient Problem Hyperglycemia (1905)

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.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.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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle libre reader were reviewed and the dhrs showed the freestyle libre reader passed all tests prior to release, correct cable and adapter was part of the kit pack, and there was no indication that the product did not meet specifications.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 battery/no power issue was reported with the adc device.Customer was unable to obtain readings due to the device's battery discharging too quickly.As a result, the customer experienced unspecified symptoms of hyperglycemia and was unable to self-treat, requiring non-hcp third-party administration of insulin for treatment.No further treatment was indicated.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and no issues were observed.Reader powered on with button depression.The user states that the reader no longer holds the charge.The reader was charged and no battery drain was observed.Issue could not be reproduced.Visually inspected the returned usb charger and usb cable and no damage was observed.Performed load test on the usb charger and results were within specification range.Visual inspection has been performed on the power adapter and no issues were observed.The power adapter voltage was measured to be within specification range.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A battery/no power issue was reported with the adc device.Customer was unable to obtain readings due to the device's battery discharging too quickly.As a result, the customer experienced unspecified symptoms of hyperglycemia and was unable to self-treat, requiring non-hcp third-party administration of insulin for treatment.No further treatment was indicated.There was no report of death or permanent impairment 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 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 19174254
• MDR Text Key: 340945490
• Report Number: 2954323-2024-14061
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 05021791002672
• UDI-Public: (01)05021791002672(91)72122-01(10)03B126F
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/27/2024

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 Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2020
• 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