MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hypoglycemia (1912); Vertigo (2134); Weakness (2145)

Event Date 09/12/2019

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 mfg 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 being unable to receive sensor scan results on the adc freestyle libre due to a "replace sensor" error message received after 10 days of sensor wear.The customer subsequently experienced a hypoglycemic episode, with symptoms of weakness and vertigo.The customer was unable to self-treat due to symptoms, so his wife performed a blood glucose test using the built-in meter with a result of 33 mg/dl and administered sugar for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(4) has been returned and investigated.Visual inspection has been performed on the returned sensor and observed damage to the center hole on the sensor piece, no other issues were observed.The sensor plug is seated properly in the mount.Extracted data from returned sensor using approved software.Sensor found to be in state 5 (indicating normal termination).The sensor plug was returned.Performed a visual inspection of the sensor tail.No issues found.Removed the plug from the sensor and inspected the plug assembly.No issues observed.Sensor was reprogrammed and perform simvivo test.All results were within specification.This issue is not confirmed.

Event Description

A customer reported being unable to receive sensor scan results on the adc freestyle libre due to a "replace sensor" error message received after 10 days of sensor wear.The customer subsequently experienced a hypoglycemic episode, with symptoms of weakness and vertigo.The customer was unable to self-treat due to symptoms, so his wife performed a blood glucose test using the built-in meter with a result of 33 mg/dl and administered sugar for treatment.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 9163874
• MDR Text Key: 161493501
• Report Number: 2954323-2019-07709
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 76