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

Model Number 71992-01

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

Patient Problems Hypoglycemia (1912); Dizziness (2194); Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 10/27/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.At this time product has not yet 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 device history records (dhrs) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.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

An alarm issue was reported with the abbott diabetes care (adc) device.The low glucose alarm did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced dizziness with "low capacity to self-treat" treating with "volume sugar", then experienced seizures and a loss of consciousness, and was unable to self-treat.Customer received third-party treatment of "sugar with water" orally by a non-healthcare professional.Customer also noted they take an insulin prescribed by a healthcare professional but it was unspecified if they were on the medication at time of event.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

An alarm issue was reported with the adc application in use with phone (iphone/ os 16.2, app: 2.8.1.6120).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).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The reported sensor was activated with a retained reader and linearity testing was performed, all results were within specification.Low glucose alarm was successfully activated.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the abbott diabetes care (adc) device in use with iphone/ os 16.2, app: 2.8.1.6120.The low glucose alarm did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced dizziness with "low capacity to self-treat" treating with "volume sugar", then experienced seizures and a loss of consciousness, and was unable to self-treat.Customer received third-party treatment of "sugar with water" orally by a non-healthcare professional.Customer also noted they take an insulin prescribed by a healthcare professional but it was unspecified if they were on the medication at time of event.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: 16302560
• MDR Text Key: 308823684
• Report Number: 2954323-2023-05509
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/14/2023

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 Expiration Date: 02/29/2024
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 03/26/2023
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2022
• 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