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

Model Number 71992-01

Device Problems No Device Output (1435); Unable to Obtain Readings (1516)

Patient Problems Hypoglycemia (1912); Convulsion/Seizure (4406)

Event Date 11/06/2021

Event Type  Injury  

Manufacturer Narrative

At this time, product has not yet been returned.The sensor kit expiration date is 31-may-2021.The medical event associated with this complaint occurred on (b)(6) 2021 which indicates usage of the device beyond the useful lifespan.No additional investigation is required as the sensor was expired at the time of use, and the device met its specification lifespan.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that upon scanning the freestyle libre 2 sensor, there was no response (scan timeout error).As a result, customer was unable to obtain readings or alarms and subsequently experienced seizure.A third-party treated the customer with glucose injection.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 properly seated and no physical damage was observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Attempted communication between returned sensor and known good reader.Reader successfully communicated with the returned sensor.Scan timeout error message was not observed.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that upon scanning the freestyle libre 2 sensor, there was no response (scan timeout error).As a result, customer was unable to obtain readings or alarms and subsequently experienced seizure.A third-party treated the customer with glucose injection.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: 12836970
• MDR Text Key: 280962747
• Report Number: 2954323-2021-93065
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2020
• 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
• Patient Weight: 82 KG