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

Model Number 71953-01

Device Problem No Device Output (1435)

Patient Problem Loss of consciousness (2418)

Event Date 07/04/2022

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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that the glucose test would not start after sample applied, with the adc device.Therefore, glucose results could not be obtained and the customer subsequently lost consciousness.The customer was assisted by family member with unspecified self-treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The reported meter ((b)(6)) has been returned and investigated.Performed visual inspection on the returned meter and no issues were observed.Performed control solution test using the returned meter and the test was satisfactory.Issue is not confirmed.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A valid serial number has not been provided for the strips.Clinical data was reviewed and confirmed that precision strips continue to be safe, effective, and perform as intended in the field.Stability data for precision strips was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and precision strips, no trends were identified that would indicate any product related issues.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that the glucose test would not start after sample applied, with the adc device.Therefore, glucose results could not be obtained and the customer subsequently lost consciousness.The customer was assisted by family member with unspecified self-treatment.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: 15021118
• MDR Text Key: 295952283
• Report Number: 2954323-2022-24193
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 10/20/2022

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: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 10/11/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other