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

Model Number 71992-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems Hypoglycemia (1912); Cognitive Changes (2551)

Event Date 07/01/2023

Event Type  Injury  

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 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

An alarm issue was reported with the adc device in use with sm-a536b with android operating system version unknown.Customer received a "scan error" message and was unable to obtain readings.As a result, customer experienced a lack of focus, irritability and lack of focus and was unable to self-treat, requiring third-party administration of sweet drink for treatment.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 sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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 adc device in use with sm-a536b with android operating system version unknown.Customer received a "scan error" message and was unable to obtain readings.As a result, customer experienced a lack of focus, irritability and lack of focus and was unable to self-treat, requiring third-party administration of sweet drink for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Attempted communication between returned sensor and known good reader.Reader successfully communicated with the returned sensor.Scan timeout error message was not observed.An extended investigation has been performed.Returned sensor complaint was investigated and determined that there were no issues with the freestyle librelink that would have led to the complaint.The customer reported scan error message.An attempt was made to reproduce the issue using similar device configuration and was not able to reproduce the complaint.Therefore the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the adc device in use with sm-a536b with android 13 and app version 2849335.Customer received a "scan error" message and was unable to obtain readings.As a result, customer experienced a lack of focus, irritability and lack of focus and was unable to self-treat, requiring third-party administration of sweet drink for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The user reported receiving a scan error message.The reported issue was investigated and attempted to replicate.The reported configuration was not compatible with the freestyle librelink app.The latest revision of the compatibility guide was available to the customer on the abbott diabetes care website.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the adc device in use with sm-a536b with android 13 and app version 2849335.Customer received a "scan error" message and was unable to obtain readings.As a result, customer experienced a lack of focus, irritability and lack of focus and was unable to self-treat, requiring third-party administration of sweet drink for treatment.There was no report of death or permanent impairment 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: 17295550
• MDR Text Key: 318742525
• Report Number: 2954323-2023-29623
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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
• Report Date: 04/09/2024

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 Expiration Date: 03/31/2024
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/21/2023; 11/27/2023; 03/21/2024
• Supplement Dates FDA Received: 07/24/2023; 12/21/2023; 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• 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