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

Model Number 71733-01

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

Patient Problems Hyperglycemia (1905); Shaking/Tremors (2515); Confusion/ Disorientation (2553); Polydipsia (2604)

Event Date 12/23/2022

Event Type  Injury  

Event Description

A caregiver reported that the adc application is incompatible with the customer's phone and therefore was unable to scan the sensor using the app.The customer reported experiencing symptoms of confusion, shaking, drinking a lot, urination, and was unable to self-treat.The customer was seen by an hcp who diagnosed them with hyperglycemia and received treatment with insulin (dose/type unknown) and iv fluids.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturing date is unknown.The date entered in the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

Extended investigation has been performed for the reported complaint and there was no indication that the librelink application did not meet specification.The customer reported an incompatible device with the librelink application.The device and phone version were not provided.Based on case information, no issues were identified with the librelink application itself.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caregiver reported that the adc application is incompatible with the customer's phone and therefore was unable to scan the sensor using the app.The customer reported experiencing symptoms of confusion, shaking, drinking a lot, urination, and was unable to self-treat.The customer was seen by an hcp who diagnosed them with hyperglycemia and received treatment with insulin (dose/type unknown) and iv fluids.There was no report of death or permanent injury 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: 16212302
• MDR Text Key: 307765453
• Report Number: 2954323-2023-03361
• 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: 03/17/2023

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
• Device Catalogue Number: 71732-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2022
• 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