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 Loss of consciousness (2418); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 10/26/2021

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.Dhrs (device history record) 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 alarm issue was reported with the freestyle libre 2 sensor.The low glucose alarm failed to trigger and customer experienced cramps and loss of consciousness.The customer received unspecified treatment from a healthcare professional, however, no further information was reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor 3mh008tw730 has been returned and investigated.A visual inspection was performed and no physical damage is observed on sensor patch.Sensor plug was properly seated in the mount.Extracted data from returned sensor using approved software.Sensor found to be in state 5 (indicating normal termination).Removed the sensor plug and inspected the plug assembly, no failure mode was observed.Set the low glucose thresholds in the reader¿s alarm settings.Activated sensor with a known good reader and performed accuracy test.Low glucose alarms were successfully activated.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the freestyle libre 2 sensor.The low glucose alarm failed to trigger and customer experienced cramps and loss of consciousness.The customer received unspecified treatment from a healthcare professional, however, no further information was reported.There was no report of death or permanent injury 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: 12776344
• MDR Text Key: 280505721
• Report Number: 2954323-2021-91565
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 06/07/2022

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: 12/31/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 05/27/2022
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2021
• 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: Female
• Patient Weight: 54 KG