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); Application Program Problem (2880)

Patient Problems Hypoglycemia (1912); Hot Flashes/Flushes (2153); Shaking/Tremors (2515)

Event Date 02/20/2023

Event Type  Injury  

Event Description

An alarm issue was reported with the adc application in use with a samsung galaxy s20 phone with android 13 operating system.The customer experienced a "signal loss" and was unable to obtain readings.As a result, customer was not alerted of changes in glucose level and experienced shaking and "feeling hot" and was unable to self-treat, requiring treatment of glucagon from a non-healthcare professional.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.

Manufacturer Narrative

Adc has identified a software defect for the freestyle libre 2/freestyle libre 3 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.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

• 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: 16497469
• MDR Text Key: 310820045
• Report Number: 2954323-2023-09224
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71857-01
• Device Lot Number: 2829318
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: QUALITY RECORD QR869957
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention