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

Model Number 71992-01

Device Problem Device Alarm System (1012)

Patient Problems Hypoglycemia (1912); Chills (2191); Shaking/Tremors (2515); Confusion/ Disorientation (2553); Convulsion/Seizure (4406)

Event Date 04/16/2022

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned.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.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarming issue was reported with the adc device.A caller reported that the sensor's low glucose alarm failed to trigger and as a result, the customer experienced symptoms described as ¿felt cold, shaking, dry at the mouth, disorientated, went blank, and seizure.¿ the customer received apple juice from the wife and an unspecified iv, ¿tube of something¿, and glucose for the diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.

Event Description

An alarming issue was reported with the adc device in use with (iphone 13/ os version- 15.4.1/ software full version- 2.7.2.3589).A caller reported that the sensor's low glucose alarm failed to trigger and as a result, the customer experienced symptoms described as ¿felt cold, shaking, dry at the mouth, disorientated, went blank, and seizure.¿ the customer received apple juice from the wife and an unspecified iv, ¿tube of something¿, and glucose for the diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The reported sensor was activated with a retained reader and linearity testing was performed, all results were within specification.Low glucose alarms were successfully activated.Issue is therefore not confirmed.All pertinent information available to abbott diabetes care has been submitted.

• 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: 14350082
• MDR Text Key: 291342687
• Report Number: 2954323-2022-15055
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: 00357599800000
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/31/2023

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 Expiration Date: 10/31/2022
• Device Model Number: 71992-01
• Device Catalogue Number: 71992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• 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 Age: 47 YR
• Patient Sex: Male
• Patient Weight: 84 KG