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

Model Number 71732-01

Device Problem Application Program Problem (2880)

Patient Problems Hypoglycemia (1912); Muscle Weakness (1967); Dizziness (2194); Shaking/Tremors (2515)

Event Date 10/08/2022

Event Type  Injury  

Event Description

A caller reported on behalf of a (child) customer who was having issues with the adc application.The caller reported that while using the librelinkup, it would not add a contact to the lla and as a result, an alert was not forwarded to the caregiver about the customer¿s low sugar levels.The customer experienced weakness, trembling, and dizziness and was treated with juice and food by the mother.There was no report of death or permanent injury associated with this event.

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 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

The user complained that the fs librelinkup application was unable to add contacts using the samsung galaxy.Attempted to replicate the users complaint using a similar configuration was performed.Investigation was unable to replicate the users complaint therefore, the issue is not confirmed.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.

Event Description

A caller reported on behalf of a (child) customer who was having issues with the adc application.The caller reported that while using the librelinkup, it would not add a contact to the lla and as a result, an alert was not forwarded to the caregiver about the customer¿s low sugar levels.The customer experienced weakness, trembling, and dizziness and was treated with juice and food by the mother.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRELINKUP
• 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: 15848870
• MDR Text Key: 304170957
• Report Number: 2954323-2022-42840
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71732-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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