MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72081-01

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/17/2022

Event Type  malfunction  

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit 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 receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.

Manufacturer Narrative

Sensor (b)(6)has been returned and investigated.Visual inspection performed on the returned sensor patch and no issue was observed.Data was extracted using approved software and extraction was successful.The watermark was observed at the base of the tail indicating the sensor being properly inserted.The returned sensor was further investigated and de-cased.Performed an internal visual inspection on the sensor¿s pcba (printed circuit board assembly); no issues were observed.Performed an smu (source measurement unit) test using connector key to ensure the sensor's electronics were functioning correctly and the returned unit did not have any glucose reading issues.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16076346
• MDR Text Key: 308208924
• Report Number: 2954323-2022-47592
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K213132
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/17/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 11/24/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1