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 Problems Nausea (1970); Dizziness (2194); Cognitive Changes (2551)

Event Date 06/27/2023

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 date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.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 high readings issue was reported with use of the abbott diabetes care (adc) device.Customer received unspecified higher sensor scan results when compared to unspecified readings obtained on an adc meter.As a result, customer experienced "fears", "dizziness", "nausea", and received unspecified third-party treatment.Adc customer service attempted to contact the reporter three times to gain additional details regarding this event, however all follow up attempts were unsuccessful.There was no report of death or permanent impairment associated with this event.Adc meter result of 36 mg/dl and sensor scan result of 484 mg/dl were plotted on a parkes error grid and fell into the "e" zone, showing the difference in values to be clinically significant.However, it is unknown when these readings were obtained in relation to the reported medical 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.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 high readings issue was reported with use of the abbott diabetes care (adc) device.Customer received unspecified higher sensor scan results when compared to unspecified readings obtained on an adc meter.As a result, customer experienced "fears", "dizziness", "nausea", and received unspecified third-party treatment.Adc customer service attempted to contact the reporter three times to gain additional details regarding this event, however all follow up attempts were unsuccessful.There was no report of death or permanent impairment associated with this event.Adc meter result of 36 mg/dl and sensor scan result of 484 mg/dl were plotted on a parkes error grid and fell into the "e" zone, showing the difference in values to be clinically significant.However, it is unknown when these readings were obtained in relation to the reported medical 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: 17285861
• MDR Text Key: 318641269
• Report Number: 2954323-2023-29440
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/18/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2024
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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