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

Model Number 71940-01

Device Problem Low Readings (2460)

Patient Problems Hyperglycemia (1905); Sweating (2444); Pallor (2468)

Event Date 09/09/2020

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 there was no indication that the product did not meet specification.Dhrs (device history review) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit 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

A caller reported that on (b)(6) 2020, the customer received a reading of 52 mg/dl on their adc freestyle libre sensor.It was further reported the customer experienced symptoms described as ¿felt hot, sweating, pale, and agitated¿ and was unable to self-treat.The customer was taken to a hospital where he was diagnosed with hyperglycemia and treatment with "steroid" injection and iv bag.There was no report of death or permanent injury associated with this event.

Event Description

A caller reported that on (b)(6) 2020, the customer received a reading of 52 mg/dl on their adc freestyle libre sensor.It was further reported the customer experienced symptoms described as ¿felt hot, sweating, pale, and agitated¿ and was unable to self-treat.The customer was taken to a hospital where he was diagnosed with hyperglycemia and treatment with "steroid" injection and iv bag.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Observed sensor plug was properly seated in the mount and no issues were observed.Sensor found to be in state 5 (indicating normal termination).Extracted data from returned sensor using approved software.Performed visual inspection on sensor plug assembly and no issues were observed.Current was applied to the sensor to perform linearity testing while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.

• 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
• MDR Report Key: 10563978
• MDR Text Key: 207886091
• Report Number: 2954323-2020-06374
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 00357599001018
• UDI-Public: 00357599001018
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: 71940-01
• Device Catalogue Number: 71940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 172