MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71926-01

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

Patient Problems Fatigue (1849); Headache (1880); Diaphoresis (2452)

Event Date 02/12/2024

Event Type  Injury  

Event Description

An alarm issue was reported with the adc device iphone xr phone with ios operating system version 17.2.1.Customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced headaches, asthenia, and cold sweats and was unable to self-treat, requiring treatment of sugar from a non-healthcare provider.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 date of event is unknown.The date entered in section b3 is " this morning around 7am " is on the same date abbott diabetes care became aware of the event.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

The user reported signal loss and was unable to obtain readings and receive glucose 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 adc device iphone xr phone with ios operating system version 17.2.1 and app version 2.10.2.7677.Customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced headaches, asthenia, and cold sweats and was unable to self-treat, requiring treatment of sugar from a non-healthcare provider.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING 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: 18759376
• MDR Text Key: 336008484
• Report Number: 2954323-2024-06337
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K193371
• 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: 02/27/2024

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: 71926-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2024
• 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