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

Model Number 71992-01

Device Problem No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2023

Event Type  Injury  

Manufacturer Narrative

This issue does not meet reportability criteria; however, it is being reported to the fda as the complaint was received via user report.At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and libre sensor, no trends were identified that would indicate any product related issues.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.If the product is returned, a physical investigation will be performed and a follow-up report submitted.3 sensors were reported (serial numbers unknown) and they have been captured under this submission.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Abbott diabetes care received a medwatch report which reported the following information: a "patient called to report product issues with 3 of his libre 2 sensors.Patient stated the first twosensors didn't work at all and the third sensor only worked for 2 days and then it stopped working.Patient stated that is 3 out of 6 sensors that were defective".No further information was provided.There was no report of any self or third-party medical treatment reported.No contact information was provided to adc, therefore adc is unable to attempt any follow up activities related to this event.Based on the information provided, there was no report of serious injury associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided.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.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.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

Abbott diabetes care received a medwatch report which reported the following information: a "patient called to report product issues with 3 of his libre 2 sensors.Patient stated the first twosensors didn't work at all and the third sensor only worked for 2 days and then it stopped working.Patient stated that is 3 out of 6 sensors that were defective".No further information was provided.There was no report of any self or third-party medical treatment reported.No contact information was provided to adc, therefore adc is unable to attempt any follow up activities related to this event.Based on the information provided, there was no report of serious injury associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided.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.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.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.This serves as a correction report.Section h10 (addtl mfg narrative) was incorrectly documented in the initial report.The correction has been made here.

Event Description

Abbott diabetes care received a medwatch report which reported the following information: a "patient called to report product issues with 3 of his libre 2 sensors.Patient stated the first twosensors didn't work at all and the third sensor only worked for 2 days and then it stopped working.Patient stated that is 3 out of 6 sensors that were defective".No further information was provided.There was no report of any self or third-party medical treatment reported.No contact information was provided to adc, therefore adc is unable to attempt any follow up activities related to this event.Based on the information provided, there was no report of serious 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: 16914378
• MDR Text Key: 315038727
• Report Number: 2954323-2023-18589
• Device Sequence Number: 1
• Product Code: QLG
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2023

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 Model Number: 71992-01
• Device Lot Number: KTP005874
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 06/26/2023; 06/26/2023
• Supplement Dates FDA Received: 07/07/2023; 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1