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

Model Number 71953-01

Device Problem Premature Discharge of Battery (1057)

Patient Problem Hypoglycemia (1912)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested for investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A battery/power issue was reported with the adc device.Customer was unable to obtain readings due to a fast draining battery.As a result, customer received insulin novlog(dose unspecified) from a third-party.Customer later reported taking dextrose gel and oral glucose to adjust blood glucose levels.No further treatment was required.There was no report of death or permanent impairment 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.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.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A battery/power issue was reported with the adc device.Customer was unable to obtain readings due to a fast draining battery.As a result, customer received insulin novlog(dose unspecified) from a third-party.Customer later reported taking dextrose gel and oral glucose to adjust blood glucose levels.No further treatment was required.There was no report of death or permanent impairment 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.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.Dhrs (device history review) for the libre reader and verification of correct cable and adapter were reviewed.The dhrs showed that the libre reader passed all tests prior to release and the correct cable and adapter were part of the kit pack.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Section h10 (additional mfg narrative) was incorrectly updated in the previous report.Correction has been made.

Event Description

A battery/power issue was reported with the adc device.Customer was unable to obtain readings due to a fast draining battery.As a result, customer received insulin novlog(dose unspecified) from a third-party.Customer later reported taking dextrose gel and oral glucose to adjust blood glucose levels.No further treatment was required.There was no report of death or permanent impairment associated with this event.

• Brand Name: LIBRE 2 READER FREESTYLE
• 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: 17088327
• MDR Text Key: 316793396
• Report Number: 2954323-2023-24250
• 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,Followup
• Report Date: 03/04/2024

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 Model Number: 71953-01
• Device Catalogue Number: 71953
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 06/28/2023; 02/29/2024
• Supplement Dates FDA Received: 07/17/2023; 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2021
• 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 Sex: Female