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

Model Number 71992-01

Device Problem Difficult to Insert (1316)

Patient Problems Hypoglycemia (1912); Shaking/Tremors (2515)

Event Date 04/01/2024

Event Type  Injury  

Manufacturer Narrative

The most probable root causes associated with this failure mode are disconnected, faulty or damaged components 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.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 determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the 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 unspecified insertion issue was reported with the adc device.The customer reported that their adc device was "missing a needle and plastic core." the customer was therefore unable to monitor glucose and experienced hypoglycemia, tremor, and loss of strength.The customer was provided candy by a non-healthcare professional for treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the returned applicator and no issues were observed.The applicator has been fired correctly, however sharp had not retracted.Loose sharp was not returned.Tried to open returned applicator and damage to the sharp carrier was observed.Lid did not peeled off completely.An extended investigation has been performed.Visual inspection has been performed on returned applicator and sensor pack and observed applicator was fired correctly but loose sharp was not returned.Damage to the sharp carrier was observed.Visual inspection has been performed on sensor pack and observed lid was not completely peeled off.Visual inspection has been performed on returned sensor and sensor was found to be in sensor state 1 (storage state).Sensor plug was not returned and no physical damage was observed on returned sensor.Unable to perform further investigation due to sensor plug and sharp was not returned.Issue will be closed to no product returned.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An unspecified insertion issue was reported with the adc device.The customer reported that their adc device was "missing a needle and plastic core." the customer was therefore unable to monitor glucose and experienced hypoglycemia, tremor, and loss of strength.The customer was provided candy by a non-healthcare professional for treatment.There was no report of death or permanent injury 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: 19140369
• MDR Text Key: 340560893
• Report Number: 2954323-2024-13346
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 05021791000876
• UDI-Public: (01)05021791000876(17)2025-05-31(10)KTP008214(91)71988-01
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/08/2024

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: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2024
• 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