MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRELINK UP; FLASH GLUCOSE MONITORING SYSTEM

Model Number 72154-01

Device Problem Application Program Problem (2880)

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

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

Extended investigation is pending at this time.A follow up will be submitted once additional information is obtained.The device manufacturing date does not apply.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 unspecified application issue was reported with the adc device in use with samsung galaxy s22 with android operating system 11.The customer¿s caregiver reported an issue with the use of freestyle librelink in conjunction with freestyle librelink up.The caregiver indicated that data is not being received, except for when the alarm goes off from the adc device.As a result, the customer experienced a loss of consciousness.The customer had contact with a healthcare professional (hcp) who administered a glucose infusion for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The freestyle librelinkup complaint was investigated and determined that there were no issues with the librelinkup application that would have led to the complaint.The user reported that data is not being received, except for when the alarm goes off.The reported issue was investigated and attempted to replicate using similar configuration and the reported issue was unable to be replicated and the system functioned as intended.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Section e1 (country) was incorrectly updated in the initial report.Correction has been made.

Event Description

An unspecified application issue was reported with the adc device in use with samsung galaxy s22 with android operating system 11 and app version 4.9.0(230040906).The customer¿s caregiver reported an issue with the use of freestyle librelink in conjunction with freestyle librelink up.The caregiver indicated that data is not being received, except for when the alarm goes off from the adc device.As a result, the customer experienced a loss of consciousness.The customer had contact with a healthcare professional (hcp) who administered a glucose infusion for treatment.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRELINK UP
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18743980
• MDR Text Key: 335808984
• Report Number: 2954323-2024-06019
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: VERIFY
• 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: 02/29/2024

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: 72154-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2024
• 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