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

Model Number 72081-01

Device Problem Device Alarm System (1012)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Nausea (1970); Discomfort (2330); Loss of consciousness (2418); Diaphoresis (2452)

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 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

An alarm issue was reported via email with the abbott diabetes care (adc) device.The low glucose alarm did not sound and customer was unaware of changes in glucose levels.As a result, customer experienced weakness, discomfort, nausea, sweating, and a loss of consciousness resulting in a head injury and was unable to self-treat, requiring non-healthcare provider treatment of treatment of a glass of milk with a chocolate drink for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection performed on the returned sensor patch and no issue was observed.Extracted data from the returned sensor using approved software.The watermark was observed at the base of the tail indicating the sensor being properly inserted.The returned sensor was further investigated and de-cased.Performed an internal visual inspection on the sensor¿s pcba (printed circuit board assembly); no issues were observed.The returned sensor was restored to storage state and activated to perform accuracy testing using connector key.All results were within specification.The sensor was restored to storage state again and activated with a known good reader to receive first 5 ble (bluetooth low energy) packets and first 5 ble packets were received.The blc count and rssi (received signal strength indicator) were present for all packets.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported via email with the abbott diabetes care (adc) device.The low glucose alarm did not sound and customer was unaware of changes in glucose levels.As a result, customer experienced weakness, discomfort, nausea, sweating, and a loss of consciousness resulting in a head injury and was unable to self-treat, requiring non-healthcare provider treatment of treatment of a glass of milk with a chocolate drink for treatment.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 94502-7001 ; 5107495297
• MDR Report Key: 19082891
• MDR Text Key: 339851595
• Report Number: 2954323-2024-12238
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 35021791003397
• UDI-Public: (01)35021791003397(17)2024-10-31(10)T60001440(91)72218-01
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K212132
• 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: 05/07/2024

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: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2023
• 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