MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72079-01

Device Problem Failure to Power Up (1476)

Patient Problems Headache (1880); Hypoglycemia (1912); Nausea (1970); Dizziness (2194)

Event Date 01/18/2024

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.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 libre reader were reviewed and the dhrs showed the libre reader 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 caregiver reported that the customer's adc device stopped charging and wouldn¿t turn on with the button pressed or with the strip inserted.The customer became hypoglycemic with symptoms of dizziness, nausea and headaches however, was able to self-treat with "long term sugar tablets and insulin injections" type/dose unknown).It was further reported that the customer had contact with a healthcare professional who obtained an unknown glucose result and provided unspecified medical treatment for the reported issue.No further information was reported.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 damaged usb port was observed.The damaged usb port would prevent the customer from charging the reader which would lead to the reader not turning on.Visual inspection was performed on the usb/charging cable and no damage was observed.Usb/charging cable was passing the test.Visual inspection was performed on the power adapter and no issues were observed.Performed load test on the returned power adapter and results were within specification range.Power adapter was passing the test.An extended investigation has been performed.Visual inspection was performed on the returned reader and damage usb charging port was observed.Returned reader was de-cased and able to pass through letterbox gauge.The returned battery voltage was measured and not within specification range.Battery was replaced and returned reader powered on.Unable to charge the battery due to damage usb charging port.This damage caused on usb charging port due to consistent misuse and the internal part of the usb socket has also been damaged which is consistent with incorrect cable insertion and misuse.As the returned charging cable and adapter both pass the testing this issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caregiver reported that the customer's adc device stopped charging and wouldn¿t turn on with the button pressed or with the strip inserted.The customer became hypoglycemic with symptoms of dizziness, nausea and headaches however, was able to self-treat with "long term sugar tablets and insulin injections" type/dose unknown).It was further reported that the customer had contact with a healthcare professional who obtained an unknown glucose result and provided unspecified medical treatment for the reported issue.No further information was reported.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18563183
• MDR Text Key: 333467413
• Report Number: 2954323-2024-03058
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K223435
• 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: 02/23/2024

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: 72079-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• 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