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

Model Number 71992-01

Device Problem Device Alarm System (1012)

Patient Problems Hypoglycemia (1912); Nausea (1970); Hot Flashes/Flushes (2153); Loss of consciousness (2418); Diaphoresis (2452)

Event Date 07/18/2022

Event Type  Injury  

Event Description

A customer reported an alarm issue with the adc device.The customer reported that the low glucose alarm failed to trigger and customer had symptoms of sweating, nausea, feeling hot, and loss of consciousness.The customer was treated with glucose tablets by third-party.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing 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.

Event Description

A customer reported an alarm issue with the adc device in use with samsung galaxy 8; os version 9; app version 2.5.3.6373.The customer reported that the low glucose alarm failed to trigger and customer had symptoms of sweating, nausea, feeling hot, and loss of consciousness.The customer was treated with glucose tablets by third-party.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

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 freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.Successfully received high/low glucose alarms on ios/fsll using a known good libre 2 sensor.No issues were identified with librelink application.Sensor (b)(6)has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.The sensor was found to be in state 5 (indicating normal termination).Plug was not returned.The reported sensor was activated with a retained reader and linearity testing was performed, all results were within specification.Low glucose alarms were successfully activated.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Section h10 (addtl mfg narrative) was incorrectly documented in the previous report.The correction has been made here.

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 freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.Successfully received high/low glucose alarms on ios/fsll using a known good libre 2 sensor.No issues were identified with librelink application.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.

Event Description

A customer reported an alarm issue with the adc device.The customer reported that the low glucose alarm failed to trigger and customer had symptoms of sweating, nausea, feeling hot, and loss of consciousness.The customer was treated with glucose tablets by third-party.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported an alarm issue with the adc device in use with samsung galaxy 8; os version 9; app version 2.5.3.6373.The customer reported that the low glucose alarm failed to trigger and customer had symptoms of sweating, nausea, feeling hot, and loss of consciousness.The customer was treated with glucose tablets by third-party.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.The sensor was found to be in state 5 (indicating normal termination).Plug was not returned.The reported sensor was activated with a retained reader and linearity testing was performed, all results were within specification.Low glucose alarms were successfully activated.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

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 freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.Successfully received high/low glucose alarms on ios/fsll using a known good libre 2 sensor.No issues were identified with librelink application.Sensor (b)(6) has been returned and investigated.No physical damage was observed on the sensor patch.The sensor was found to be in state 5 (indicating normal termination).Plug was not returned.The reported sensor was activated with a retained reader and linearity testing was performed, all results were within specification.Low glucose alarms were successfully activated.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Section h10 (addtl mfg narrative) was incorrectly documented in the #3 follow up report.The correction has been made here.

Event Description

A customer reported an alarm issue with the adc device in use with samsung galaxy 8; os version 9; app version 2.5.3.6373.The customer reported that the low glucose alarm failed to trigger and customer had symptoms of sweating, nausea, feeling hot, and loss of consciousness.The customer was treated with glucose tablets by third-party.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: 15225546
• MDR Text Key: 297892937
• Report Number: 2954323-2022-29034
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention