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

Model Number 71733-01

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

Patient Problems Fatigue (1849); Hyperglycemia (1905); Nausea (1970); Dizziness (2194)

Event Date 08/18/2023

Event Type  Injury  

Manufacturer Narrative

An extended investigation is pending at this time.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

A customer reported being unable to obtain readings while using the adc sensor with the freestyle librelink application.As a result, customer experienced symptoms described as "dizziness, fatigue, nausea, dehydration" and was unable to self-treat.Customer had contact with a healthcare professional who provided electrolytes due to dehydration, an unspecified (dose/type) insulin as treatment for the diagnosis of hyperglycemia and obtained an unspecified blood glucose reading.There was no report of death or permanent impairment associated with this event.

Event Description

A customer reported being unable to obtain readings while using the adc sensor with the freestyle librelink application.As a result, customer experienced symptoms described as "dizziness, fatigue, nausea, dehydration" and was unable to self-treat.Customer had contact with a healthcare professional who provided electrolytes due to dehydration, an unspecified (dose/type) insulin as treatment for the diagnosis of hyperglycemia and obtained an unspecified blood glucose reading.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

An extended investigation was performed on the reported complaint and determined that there were no issues with the librelink application that would have led to the complaint.The customer reported that no message showing when scanning the sensor.Successfully start sensor and received glucose reading and alarm notifications and was unable to reproduce the complaint.Therefore, the issue is not confirmed.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: 17785857
• MDR Text Key: 323890897
• Report Number: 2954323-2023-41505
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 00357599000042
• UDI-Public: 00357599000042
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/04/2023

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: 71733-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• 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