MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRELINK; DATA MANAGEMENT SYSTEM

Model Number 71732-01

Device Problems Unable to Obtain Readings (1516); Application Program Problem (2880)

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

Event Date 01/21/2024

Event Type  Injury  

Event Description

An incompatible os issue was reported with the adc device in use with galaxy a53 5g unknown operating system version.The customer was unable to access their freestyle librelink account due to incompatibility issues.As a result, the customer was unable to monitor glucose with sensor readings and experienced loss of consciousness and was unable to self-treat.The ambulance was called to the customer home.Upon arrival, the healthcare professional (hcp) administered glucose injection as treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.

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 incompatible os issue was reported with the adc device in use with galaxy a53 5g unknown operating system version and unknown app version.The customer was unable to access their freestyle librelink account due to incompatibility issues.As a result, the customer was unable to monitor glucose with sensor readings and experienced loss of consciousness and was unable to self-treat.The ambulance was called to the customer home.Upon arrival, the healthcare professional (hcp) administered glucose injection as treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The user reported being unable to scan due to the nfc not working.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.As the compatibility guide was provided to the customer and the incompatible configurations were used, this complaint is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRELINK
• Type of Device: DATA MANAGEMENT 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: 18668785
• MDR Text Key: 334948084
• Report Number: 2954323-2024-04792
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

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: 71732-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2024
• 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