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

Model Number 72081-01

Device Problem Material Twisted/Bent (2981)

Patient Problem Loss of consciousness (2418)

Event Date 06/22/2023

Event Type  Injury  

Manufacturer Narrative

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

A bent sensor tip was reported with the adc device and customer was therefore unable to apply the device and monitor glucose levels.As a result, the customer experienced a loss of consciousness, redness at the sensor site and was able to self-treat with unspecified oral medication.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 was performed on the returned sensor patch, no issues were observed.No issues were observed with the sensor adhesive.A watermark at the base of the sensor tail was observed, this is an indication that the sensor was properly inserted.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A bent sensor tip was reported with the adc device and customer was therefore unable to apply the device and monitor glucose levels.As a result, the customer experienced a loss of consciousness, redness at the sensor site and was able to self-treat with unspecified oral medication.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: 17299436
• MDR Text Key: 318918208
• Report Number: 2954323-2023-29761
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 30357599818006
• UDI-Public: 30357599818006
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/15/2024

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 Expiration Date: 12/31/2023
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2023
• 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
• Patient Sex: Female