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

Model Number 71992-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/13/2023

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 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.The date the incident occurred is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A webform complaint was received in which it was reported a customer experienced a bleeding issue with the adc device.The customer was given unspecified treatment by a third-party.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor applicator (b)(6) has been returned and investigated.Visual inspection has been performed on the applicator and no issues were observed.Applicator had fired correctly.The applicator was pried open to inspect the sharp; no issues was observed with the sharp.Sensor pack (b)(6) has been returned and investigated.Visual inspection has been performed on the sensor pack and observed damaged transition features.Lid was completely peeled off.Unable to perform further investigation due to no product returned.Issue close to no product returned.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A webform complaint was received in which it was reported a customer experienced a bleeding issue with the adc device.The customer was given unspecified treatment by a third-party.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 CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 17302536
• MDR Text Key: 318824869
• Report Number: 2954323-2023-29794
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 07/20/2023

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: 06/13/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/15/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2023
• 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