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

Model Number 71992-01

Device Problems Material Separation (1562); Failure to Deliver (2338)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Diaphoresis (2452); Confusion/ Disorientation (2553)

Event Date 04/18/2021

Event Type  Injury  

Manufacturer Narrative

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 record) for the libre sensor and libre sensor kit were reviewed, and the dhrs showed the libre sensor and libre 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

A caller reported that the freestyle libre 2 sensor pack had a loose applicator needle, and as a result the sensor could not be applied.The customer was unable to monitor glucose and subsequently became pale, sweaty, incoherent, and lost consciousness.The customer obtained a glucose result of 32 mg/dl from unknown device, and was treated with honey-water by a third-party.There was no report of death or permanent injury associated with this event.

Event Description

A caller reported that the freestyle libre 2 sensor pack had a loose applicator needle, and as a result the sensor could not be applied.The customer was unable to monitor glucose and subsequently became pale, sweaty, incoherent, and lost consciousness.The customer obtained a glucose result of 32 mg/dl from an unknown device and was treated with honey water by a third party.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visually inspect the sensor and no damages were observed.Performed a visual inspection on the returned applicator and no damages were observed.The applicator was fired, and the sharp was not retracted.Visually inspected the sensor pack and observed platform initial lock was sitting towards the outside of the platform initial lock ledge.Both sharp and plug were still in the pack.The lid was not completely peeled off.The issue was further investigated.Performed a visual inspection on the returned sensor pack and it was determined that contact between one of the platform initial locks on the platform and the tray¿s corresponding initial lock ledge prevented the platform from lowering.The application of pressure, more than required for normal assembly, would cause the platform initial lock to buckle or slide down the outside surface of the initial lock ledge, further preventing the platform from lowering correctly.An investigation also determined that a tilt in the platform relative to the tray displaced the platform initial lockout of the position specified by the design.It was determined that the reported issue stems from a misalignment between the platform and the tray during the assembly of the sensor pack.Therefore, this has been confirmed to be a manufacturing issue.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
• MDR Report Key: 11745151
• MDR Text Key: 247943579
• Report Number: 2954323-2021-67875
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 62