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

Model Number 72077-01

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

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

Event Date 01/15/2024

Event Type  Injury  

Event Description

An alarm issue was reported with the adc device in use with an unspecified iphone model with ios operating system version 17.1.2.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 hypoglycemia, dizziness and a loss of consciousness and was unable to self-treat, requiring non-hcp third-party administration of orange juice and candy for treatment.No further treatment was indicated.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The most probable root causes associated with this failure mode are software/data corruption or misuse.However, mitigations are in place to reduce and prevent such issues.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.The customer reported missing low alarm due to signal loss.The reported issue was investigated and attempted to be replicated using similar configurations of iphone 12, ios 17.1.2, 3.5.0.8863.The reported issue was unable to be replicated and the system functioned as intended.There were no issues identified with the freestyle libre 3 app during replication that would have led to the reported issue.Sensor 0fk6rdnkf has been returned and investigated.Visual inspection has been performed on sensor and no issues were observed.The sensor plug was seated in mount properly.Data was successfully extracted from the returned sensor using approved software.Removed the sensor plug and inspected the plug assembly, no failure mode observed.The sensor was activated with a known good reader and the bluetooth connection was successful.Linearity test was performed while the reader was wrapped in aluminum foil (to simulate signal loss), signal loss message was not observed and therefore functioning properly.Therefore, the 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.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and sensor kit passed all tests prior to release.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.The sensor was activated with a known good reader and the bluetooth connection was successful.Sensor was de-cased and linearity test was performed while the reader was wrapped in aluminum foil (to simulate signal loss); signal loss message did not 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 an smu (source measurement unit) test to ensure the sensor's electronics were functioning correctly, and the returned unit did not have any glucose reading issues.Also monitor bluetooth connection for any missing data throughout the test and no issues were observed.Which indicates that the returned puck did not have any defects that would cause signal/connection issues.No signal loss messages or alarms were observed during test, which indicates that the sensor was fully functional.Therefore, this issue is not confirmed.The customer reported missing low alarm due to signal loss.The reported issue was investigated and attempted to be replicated using similar configurations.The reported issue was unable to be replicated and the system functioned as intended.There were no issues identified with the freestyle libre 3 app during replication that would have led to the reported issue.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.This also serves as a correction report.Section h10 (additional mfg narrative) was incorrectly updated in the initial report.Correction has been made.

Event Description

An alarm issue was reported with the adc device in use with an unspecified iphone model with ios operating system version 17.1.2 and app version 3.5.0.8863.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 hypoglycemia, dizziness and a loss of consciousness and was unable to self-treat, requiring non-hcp third-party administration of orange juice and candy for treatment.No further treatment was indicated.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: 18659502
• MDR Text Key: 334763363
• Report Number: 2954323-2024-04631
• Device Sequence Number: 1
• Product Code: QLG
• 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,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 72077-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Male