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

Model Number 71940-01

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

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered in 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 bent sensor tip was reported with the freestyle libre sensor and customer was therefore unable to apply the device and monitor glucose levels.As a result, the customer experienced a loss of consciousness and was unable to self-treat, requiring treatment of sugar by a third-party.There was no report of death or permanent injury associated with this event.

Event Description

A bent sensor tip was reported with the freestyle libre sensor and customer was therefore unable to apply the device and monitor glucose levels.As a result, the customer experienced a loss of consciousness and was unable to self-treat, requiring treatment of sugar by a third-party.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Additional information: section d4 (expiration date) and h4 (device mfg date) were updated based on the extended investigation.No product has 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 specifications.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.If the 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 14 DAY
• 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: 12443411
• MDR Text Key: 270475490
• Report Number: 2954323-2021-83535
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• 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: 71940-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 60