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

Model Number 71992-01

Device Problems Difficult to Insert (1316); Unable to Obtain Readings (1516); Material Twisted/Bent (2981)

Patient Problems Hyperglycemia (1905); Loss of consciousness (2418)

Event Date 05/23/2021

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 review) 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

Customer reported the freestyle libre 2 sensor had a bent sensor tip and did not apply properly, which resulted in the inability to obtain readings.As a result, customer experienced a loss of consciousness and, upon regaining consciousness, self-treated with insulin (dose/type unspecified).No further treatment was reported.There was no report of death or permanent impairment associated with this event.

Event Description

Customer reported the freestyle libre 2 sensor had a bent sensor tip and did not apply properly, which resulted in the inability to obtain readings.As a result, customer experienced a loss of consciousness and, upon regaining consciousness, self-treated with insulin (dose/type unspecified).No further treatment was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6) was returned and investigated.Visual inspection was performed n the returned sensor and no issue was observed.The sensor plug was returned and properly seated.A watermark was observed at the base of the tail.Performed a visual inspection on the returned applicator; no issue was observed, the applicator had been fired.However, unable to perform further investigation due to the sensor pack not being returned.If the remaining product is returned, the case will be re-opened, and a physical investigation will be performed.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: 11969758
• MDR Text Key: 255317822
• Report Number: 2954323-2021-71847
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR