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

Model Number 71953-01

Device Problem Power Problem (3010)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Dizziness (2194); Confusion/ Disorientation (2553)

Event Date 09/12/2022

Event Type  Injury  

Manufacturer Narrative

Reader megb292-g1593 has been returned as in currently undergoing investigation process.A follow-up report will be submitted all investigation activities are complete.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that the adc device would occasionally not power on.The customer reported developing symptoms of dizziness, fatigue, and confusion but was unable to obtain glucose results and lost consciousness.The customer was treated with glucagon injection by spouse.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection was performed and no issues were observed.The reader powered on with button press however, a power issue was observed as the reader randomly powered on and off.Further investigation was peformed and the reader was de-cased.Visual inspection was performed and no issues were observed.The returned battery was measured and the reader was placed in the pcba (printed circuit board assembly) test fixture.Pressure was applied to the cpu (central processing unit), the reader powered on and the battery was charging.Reader stayed on and functioned properly.Extended investigation was also performed.Visual inspection was performed and no signs of damage or contamination were observed.The reader continued to display the power issue of randonly powering on and off and returing to the home screen.Pressure was again applied to the cpu and the power issue is no longer observed.There the issue is confirmed to a faulty cpu solder.The dhrs (device history review) for the fs libre reader were reviewed and the dhrs 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 customer reported that the adc device would occasionally not power on.The customer reported developing symptoms of dizziness, fatigue, and confusion but was unable to obtain glucose results and lost consciousness.The customer was treated with glucagon injection by spouse.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: 15554310
• MDR Text Key: 301328988
• Report Number: 2954323-2022-36883
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• UDI-Public: 00357599803001
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Device Catalogue Number: 71953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female