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

Model Number 71992-01

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Pain (1994); Device Embedded In Tissue or Plaque (3165); Skin Infection (4544); Swelling/ Edema (4577)

Event Date 12/13/2022

Event Type  Injury  

Event Description

A customer reported that the adc device sensor tip was left in their body and as a result, the customer experienced symptoms of bruised, pain, and swelling at the insertion site.The customer had contact with a healthcare professional who remove the sensor and a "metal part" from the customer's arm and provided bacitracin gel for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

At this time product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.The dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.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.

Manufacturer Narrative

Sensor (b)(6)was returned and investigated.Visual inspection was performed, and no issues were observed.Visual inspection was performed on the returned adhesive and no issues were observed.No malfunction or product deficiency was identified.This issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that the adc device sensor tip was left in their body and as a result, the customer experienced symptoms of bruised, pain, and swelling at the insertion site.The customer had contact with a healthcare professional who remove the sensor and a "metal part" from the customer's arm and provided bacitracin gel for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

(b)(6) has been returned and investigated.Visual inspection has been performed and no damage was observed.Sensor plug assembly was loose with sharp stuck inside.Sensor applicator (b)(6) has been returned and investigated.Visual inspection has been performed on the applicator and no damage was observed.Applicator had fired correctly.Unable to perform further investigation due to sensor pack not returned.If the sensor pack 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 device sensor tip was left in their body and as a result, the customer experienced symptoms of bruised, pain, and swelling at the insertion site.The customer had contact with a healthcare professional who remove the sensor and a "metal part" from the customer's arm and provided bacitracin gel for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

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.This serves as a correction report.Section h10 (additional mfg narrative) was incorrectly updated in the initial report.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that the adc device sensor tip was left in their body and as a result, the customer experienced symptoms of bruised, pain, and swelling at the insertion site.The customer had contact with a healthcare professional who remove the sensor and a "metal part" from the customer's arm and provided bacitracin gel for treatment.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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16132069
• MDR Text Key: 307017265
• Report Number: 2954323-2023-01573
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: 00357599800000
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Model Number: 71992-01
• Device Catalogue Number: 71992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• 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