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

Model Number 71992-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 07/14/2021

Event Type  Injury  

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.Dhrs (device history review) for the freestyle libre sensor and sensor kit were reviewed and the dhrs showed the freestyle libre sensor and 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.

Event Description

Caller reported that the "applicator needle was stuck in the skin" after insertion of an adc freestyle libre 2 sensor and customer experienced pain in the arm.Customer had contact with the doctor who removed the needle and placed a suture.No further treatment was reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor 3mh004c402m has been returned and investigated.Visual inspection has been performed on the returned applicator and no issues were observed.Applicator had been fired, however, the sharp was stuck inside the sensor plug assembly, indicating improper assembly by the user.A visual inspection was performed on the sensor pack and no issues were observed.The lid was observed completely peeled off.The platform was inspected, and no issues were observed.Visual inspection was performed on the returned sensor; no issues were observed.The inspection was performed on sensor plug assembly and sharp was observed stuck inside.This issue is not confirmed to use due to an incorrect assembly method.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Caller reported that the "applicator needle was stuck in the skin" after insertion of an adc freestyle libre 2 sensor and the customer experienced pain in the arm.Customer had contact with the doctor who removed the needle and placed a suture.No further treatment was reported.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: 12243391
• MDR Text Key: 264029002
• Report Number: 2954323-2021-77843
• 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: 02/01/2022

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: 06/30/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 01/17/2022
• Supplement Dates FDA Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2021
• 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
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 51 KG