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

Model Number 71733-01

Device Problem Application Program Problem (2880)

Patient Problems Fatigue (1849); Diabetic Ketoacidosis (2364); Loss of consciousness (2418); Shaking/Tremors (2515)

Event Date 02/16/2024

Event Type  Injury  

Event Description

An unspecified issue was reported with the adc device in use with iphone 14 with ios operating system version 17.4.The customer was unable to access their freestyle librelink due to a scanning issue.As a result, the customer experienced diabetic ketoacidosis (dka) with symptoms described as shakiness, lethargic, generally unwell, and a loss of consciousness; however, after regaining consciousness the customer was able to self-treat with glucose.In addition, the customer reported to have been hospitalized and was administered intravenous glucose for treatment.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.

Manufacturer Narrative

An extended investigation has been performed on the reported software, per the abbott diabetes care compatibility guide for the freestyle librelink app the reported configuration of ios 17.4 is not compatible with the freestyle librelink app.The latest revision of the compatibility guide is available to the customer on the abbott diabetes care website.As the compatibility guide is provided to the customer and the incompatible configurations were used.Therefore, this complaint is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An unspecified issue was reported with the adc device in use with iphone 14 with ios operating system version 17.4.The customer was unable to access their freestyle librelink due to a scanning issue.As a result, the customer experienced diabetic ketoacidosis (dka) with symptoms described as shakiness, lethargic, generally unwell, and a loss of consciousness; however, after regaining consciousness the customer was able to self-treat with glucose.In addition, the customer reported to have been hospitalized and was administered intravenous glucose for treatment.There was no report of death or permanent impairment associated with this event.

• 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: 18867763
• MDR Text Key: 337243822
• Report Number: 2954323-2024-08121
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71733-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention