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

Model Number 71940-01

Device Problem High Readings (2459)

Patient Problems Hypoglycemia (1912); Weakness (2145); Pallor (2468)

Event Date 04/14/2019

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 caregiver reported a high readings issue with a customer's adc freestyle libre.A sensor scan result of 'hi' (reading over 500 mg/dl) was received, compared to a built-in meter reading of 34 mg/dl, while the customer was experiencing pallor and weakness.The mother of the customer administered a strawberry candy as treatment.No further treatment or intervention was reported.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 and no issues were observed.Extracted data from returned sensor using approved software.Sensor found to be in state 5 (indicating normal termination).Sensor plug was properly seated in the mount.Removed the sensor plug and inspected the plug assembly, no issues were observed.Sensor was reprogrammed and current was applied to perform linearity testing while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.Therefore, it is not confirmed.This serves as a correctional report as serial number was updated from (b)(4) in the final report.

Event Description

A caregiver reported a high readings issue with a customer's adc freestyle libre.A sensor scan result of 'hi' (reading over 500 mg/dl) was received, compared to a built-in meter reading of 34 mg/dl, while the customer was experiencing pallor and weakness.The mother of the customer administered a strawberry candy as treatment.No further treatment or intervention was reported.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: tara williamson ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 8574758
• MDR Text Key: 143866429
• Report Number: 2954323-2019-03574
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• 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?: No
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2019
• 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: 8 YR
• Patient Weight: 28