MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72081-01

Device Problem Device Alarm System (1012)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Dizziness (2194); Loss of consciousness (2418)

Event Date 03/24/2024

Event Type  Injury  

Event Description

An alarm issue was reported with the abbott diabetes care (adc) device in use with iphone (unknown model) with ios operating system version 17.3.1.The customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and experienced tiredness, dizziness, and a loss of consciousness.The customer was unable to self-treat, requiring treatment of coca-cola and cookies by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Product has been returned and investigation is in process.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.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on sensor patch and no issues were observed.Data was extracted using approved software, and extraction was successful.Visual inspection was performed on the sensor tail and no issues were observed.An extended investigation was performed.Visual investigation has been performed on the returned sensor and no issues were observed.Data was extracted using approved software, and extraction was successful.Performed a source measure unit (smu) test on the returned sensor and monitored bluetooth connection for any missing data throughout the test.No issues were observe during the test or any abnormal smu test results.Which indicates that the returned puck did not have any defects that would cause signal/connection issues.No product malfunctions were observed during investigation.Therefore, this issue is not confirmed.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs(device history review) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs (device history review) showed the fs libre sensor and sensor kit passed all tests prior to release.The user reported signal loss.The reported issue was investigated and attempted to replicate.The reported configuration was not compatible with the freestyle libre 3 app.The latest revision of the compatibility guide was available to the customer on the abbott diabetes care website.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 iphone (unknown model) with ios operating system version 17.3.1 and app version 3.5.0.8863.The customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and experienced tiredness, dizziness, and a loss of consciousness.The customer was unable to self-treat, requiring treatment of coca-cola and cookies by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 19133175
• MDR Text Key: 340480228
• Report Number: 2954323-2024-13248
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 30357599818006
• UDI-Public: (01)30357599818006(17)2024-08-31(10)T60001758(91)72081-01
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212132
• 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
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Date Manufacturer Received: 03/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2024
• 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
• Patient Sex: Male