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

Model Number 71733-01

Device Problems Device Alarm System (1012); Application Program Problem (2880)

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

Event Date 02/06/2024

Event Type  Injury  

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.Section d.Suspected medical device and g4 - pma/510(k)# has been populated for the freestyle librelink ios application as this report concerns a uk customer.This is same/similar to us freestyle libre 2 ios application part number 71926-01.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the abbott diabetes care (adc) device in use with a iphone 15 with ios operating system version 17.1.1.The customer reported that the sensor failed to alarm when their glucose level was low.As a result, the customer experienced loss of consciousness and was unable to self-treat.The customer was provided glucogel injections by a non-healthcare professional for treatment and then went to a hospital but no additional treatment was provided.No further information was provided.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The user reported missing low alarms.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.

Event Description

An alarm issue was reported with the abbott diabetes care (adc) device in use with a iphone 15 with ios operating system version 17.1.1 and app version 21027677.The customer reported that the sensor failed to alarm when their glucose level was low.As a result, the customer experienced loss of consciousness and was unable to self-treat.The customer was provided glucogel injections by a non-healthcare professional for treatment and then went to a hospital but no additional treatment was provided.No further information was provided.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: 18893515
• MDR Text Key: 337528431
• Report Number: 2954323-2024-08390
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 00357599000059
• UDI-Public: 00357599000059
• 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: 03/21/2024

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: 71733-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2024
• 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