MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)

Patient Problem Loss of consciousness (2418)

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

The reported product is not expected to be returned as reporter indicated the device was discarded.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 review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.The date of event is unknown.The date entered 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 complaint was received regarding the bent sensor when applying the adc device and therefore was unable to monitor their blood glucose.The customer had a loss of consciousness and could not recall additional information regarding the medical event.No third-party medical treatment was reported.No further information was provided.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 14 DAY
• 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: 14598553
• MDR Text Key: 293333474
• Report Number: 2954323-2022-18107
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 00357599001018
• UDI-Public: 00357599001018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160030
• 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
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: 71940-01
• Device Catalogue Number: 71940
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female