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

Model Number 71992-01

Device Problem High Readings (2459)

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

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

Adc has investigated this complaint.The sensor serial number reported in this complaint is unknown, therefore the related tripped trend reports were reviewed.A trend was identified between ((b)(6)2021 ¿ (b)(6)2022.The trend concluded that there was no product related issue.A review of potentially related complaint investigations identified an issue for which an action was taken in the field related to specific sensors which did not meet product design specification and may produce high readings that are not clinically acceptable.These specific lots were distributed to canada, japan, saudi arabia, and uk markets beginning (b)(6) 2022 (distributed after the identified tripped trend).However, as the serial number is unknown, it is not possible to confirm if this complaint is related to the action taken in the field.If product is returned no further investigation actions are required as this issue is confirmed to fa1004-2023.The device mfg date is unknown.The date entered in section h4 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 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 or out of range.There is a known issue for high readings, addressed by adc fa1004-2023, and it is unknown if the complainant product is related to this field action.The impacted product associated with this complaint has not been distributed in the usa.Impacted product was distributed to canada, japan, saudi arabia, and united kingdom.Adc field action fa1004-2023 was issued only to impacted countries.There was no report of death, serious injury, or mistreatment 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: 18417486
• MDR Text Key: 331579603
• Report Number: 2954323-2023-55506
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: QUALITY RECORD QR864898
• Patient Sequence Number: 1