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

Model Number 71953-01

Device Problem Battery Problem (2885)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 04/28/2022

Event Type  Injury  

Manufacturer Narrative

The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller reported that the adc device would power on, however, was unable to be charged.Due to this, the customer was unable to monitor glucose and experienced drowsiness and loss of consciousness.The customer was treated with glucagon, orange juice, and bread with jam by parent.There was no report of death or permanent injury associated with this event.

Event Description

A caller reported that the adc device would power on, however, was unable to be charged.Due to this, the customer was unable to monitor glucose and experienced drowsiness and loss of consciousness.The customer was treated with glucagon, orange juice, and bread with jam by parent.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 and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and libre reader, no trends were identified that would indicate any product related issues.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.Note: the device manufacturer date for the reported meter serial number is invalid.The date entered in section h4 is the date abbott diabetes care became aware of the event.Upon extended investigation, it was determined that the serial number provided by the customer ((b)(6)) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unknown.

Manufacturer Narrative

The returned (b)(6) reader was investigated.Visual inspection was performed on returned reader.Reader powered on with button depression however, it did not charge.Reader powered on again with button depression and was placed on charge and seen to be charging sufficiently.Issue was not able to be reproduced.The complaint was not confirmed.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.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 caller reported that the adc device would power on, however, was unable to be charged.Due to this, the customer was unable to monitor glucose and experienced drowsiness and loss of consciousness.The customer was treated with glucagon, orange juice, and bread with jam by parent.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: 14372575
• MDR Text Key: 291482955
• Report Number: 2954323-2022-15309
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2021
• 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