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

Model Number 71953-01

Device Problem Activation Problem (4042)

Patient Problem Hypoglycemia (1912)

Event Date 01/31/2023

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

Event Description

A touchscreen issue was reported with the abbott diabetes care (adc) reader.As a result, customer experiencing a loss of consciousness "for 1.5 hours", was unable to self-treat, and no third-party treatment was reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Additional information: section d4 (udi) has been updated based on the extended investigation.Reader (b)(6) was returned and investigated with retained strips.Performed visual inspection on returned reader and observed damage to usb (universal serial bus) port.The damaged usb port would prevent the customer from charging the reader which would lead to the reader not turning on.The reader was further investigated and de-cased.Placed into the reader test fixture and the reader log was successfully downloaded.This issue is not confirmed to use due to damaged usb port.The reader was further investigated and de-cased and no issues were observed upon visual inspection.Placed returned reader into the reader test fixture.Issue is not confirmed to use due to damaged universal serial bus (usb) port.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A dhr (device history review) for the fs libre reader was reviewed and the dhr showed the fs libre reader passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A touchscreen issue was reported with the abbott diabetes care (adc) reader.As a result, customer experiencing a loss of consciousness "for 1.5 hours", was unable to self-treat, and no third-party treatment was reported.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: 17377555
• MDR Text Key: 319599624
• Report Number: 2954323-2023-31832
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• 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
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other