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

Model Number 71857-01

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Application Program Problem (2880)

Patient Problems Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 01/31/2023

Event Type  Injury  

Manufacturer Narrative

The reported product is not expected to be returned as reporter indicated the device was discarded.Physical investigation of product is not anticipated.Extended investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of all required investigation activities.The device mfg date is unknown.The date entered in is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the adc device.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced hypotension, loss of consciousness and convulsion.Customer was unable to self-treat, requiring third-party administration of honey and juice for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.

Event Description

An alarm issue was reported with the adc device.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced hypotension, loss of consciousness and convulsion.Customer was unable to self-treat, requiring third-party administration of honey and juice for treatment.No further information was provided.There was no report of death or permanent injury associated with this 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.

Manufacturer Narrative

Adc has identified a software defect for the freestyle libre 2 application with the android 13 os where the application may experience intermittent signal loss.As a result, the application user may not receive glucose results and/or glucose alarms and may not be alerted of low or high glucose conditions.Based on the investigation, this complaint is confirmed.This issue was addressed in the field by adc fa1010-2023.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the adc application in use with a samsung a53 v.2.8.2.9318) phone android 13 operating system.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced hypotension, loss of consciousness and convulsion.Customer was unable to self-treat, requiring third-party administration of honey and juice for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.The impacted product associated with this complaint is on market in the united states as well as the following countries ous: au, at, be, hr, cz, dk, fi, fr, de, gr, il, it, kw, lu, nl, nz, no, pl, pt, qa, sa, es, se, ch, tw, ae, gb, ca.Field action fa1010-2023 was issued to all impacted countries 08feb23.

• 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: 16311885
• MDR Text Key: 308938688
• Report Number: 2954323-2023-05790
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: 00357599800000
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K210943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Model Number: 71857-01
• Device Catalogue Number: 71992
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 02/08/2023; 04/18/2023
• Supplement Dates FDA Received: 02/21/2023; 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: QR869957
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention