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

Model Number 71992-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Skin Inflammation (2443); Device Embedded In Tissue or Plaque (3165)

Event Date 10/24/2020

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 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, 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 customer reported that the adc freestyle libre sensor needle still in the skin.On (b)(6) 2020, the customer had contact with a healthcare professional, and an x-ray was performed and on (b)(6) 2020, an unspecified spray and bandage were applied due to inflammation.On (b)(6) 2020, the hcp removed the needled and no further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Section d4: (serial number) has been updated from (b)(6) to (b)(6) based on the returned product.Section d4: (expiration date) has been updated, based on the returned product download.Section g1: (contact office first name, contact office last name, contact office phone number and contact office email) has been updated.Section h4: (device mfg date) has been updated, based on the returned product download.Sensor (b)(6) has been returned and investigated.Visual inspection performed on the returned sensor and no damage was observed.The sensor plug was not returned.Further investigation was not performed, as the sensor plug was not returned.No malfunction or product deficiency was identified.An extended investigation has also been performed, based on the returned product serial number.The dhrs (device history record) 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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported, that the adc freestyle libre sensor needle still in the skin.On (b)(6) 2020, the customer had contact with a healthcare professional.And an x-ray was performed and on (b)(6) 2020.An unspecified spray and bandage were applied, due to inflammation.On (b)(6) 2020, the hcp removed the needled.And no further information was provided.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
• MDR Report Key: 10817529
• MDR Text Key: 215537259
• Report Number: 2954323-2020-10299
• 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: 03/22/2021

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: 05/31/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 50