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 Bruise/Contusion (1754); Pain (1994); Device Embedded In Tissue or Plaque (3165); Swelling/ Edema (4577)

Event Date 08/16/2022

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 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 customer reported that during the adc device insertion, the sensor tip remains in the skin and they experienced pain, bruising, and swelling.The customer had contact with a healthcare provider who performed an ultrasound, administered shots to numb the area, and then removed the needle.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.Sensor kit expiration date is 31-may-22.Medical event associated with this complaint case occurred on 16-aug-22 which confirms the usage of the device beyond the useful life of the device.Additional investigation activities are not required as the device met specification when it was released and throughout its lifespan.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 during the adc device insertion, the sensor tip remains in the skin and they experienced pain, bruising, and swelling.The customer had contact with a healthcare provider who performed an ultrasound, administered shots to numb the area, and then removed the needle.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: 15811502
• MDR Text Key: 303795285
• Report Number: 2954323-2022-42154
• 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
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Device Catalogue Number: 71992
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Female