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

Model Number 71992-01

Device Problem Low Readings (2460)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Loss of consciousness (2418); Diaphoresis (2452)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.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.

Event Description

Customer received lower sensor scan results compared to readings obtained on a competitor brand device and experienced loss of consciousness, sweating, ¿vibration, shifting¿, loss of strength and could no longer walk.Customer was unable to self-treat and was administered sandwich with jam, lemonade, syrup, a glass of cola and a cup of tea "with lots of sugar" by a healthcare professional (hcp) for treatment.No further treatment was reported.There was no report of death or permanent impairment 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).Inspected the plug assembly.Cracked sensor neck was observed.The cause of the cracked sensor neck is likely attributed to shipment of the used sensor back to adc for investigation.Sensor state 5 is an indication of normal sensor termination and full wear by the user, therefore the cracked sensor neck observed during investigation occurred post-wear.In addition, the passing of all tests during the investigation indicates that the cracked sensor neck did not impact the sensor's ability to still generate an accurate glucose reading.Current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.Therefore, the issue is not confirmed.This serves as a correction report.Section h11 (addtl mfg narrative) was incorrectly documented in the previous report.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer received lower sensor scan results compared to readings obtained on a competitor brand device and experienced loss of consciousness, sweating, ¿vibration, shithing¿, loss of strength and could no longer walk.Customer was unable to self-treat and was administered sandwich with jam, lemonade, syrup, a glass of cola and a cup of tea "with lots of sugar" by a healthcare professional (hcp) for treatment.No further treatment was reported.There was no report of death or permanent impairment 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 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 18959248
• MDR Text Key: 338361700
• Report Number: 2954323-2024-09754
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 05021791002917
• UDI-Public: (01)05021791002917(17)241031(10)7240045(91)72148-01
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2024
• 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