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 Fainting (1847); Hyperglycemia (1905); Seizures (2063)

Event Date 06/21/2019

Event Type  Injury  

Manufacturer Narrative

The reported product is not expected to be returned.A follow-up report will be filed if product is returned or 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

Customer reported receiving a "replace sensor" message after one day of wearing the adc freestyle libre sensor and being unable to obtain glucose results.Customer experienced hyperglycemia and had a seizure and "fainted" and was seen at a hospital where readings of 10 mmol/l, 13 mmol/l, and 16 mmol/l were obtained.Customer was diagnosed with hyperglycemia and also reportedly administered betahistine (anti-vertigo medication) and amoxicillin (antibiotic).Customer also underwent an mri as doctor suspected a concussion as a result of fainting.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Device manufactured date has been updated based on report.No product has been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and sensor kit were reviewed and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.

Event Description

Customer reported receiving a "replace sensor" message after one day of wearing the adc freestyle libre sensor and being unable to obtain glucose results.Customer experienced hyperglycemia and had a seizure and "fainted" and was seen at a hospital where readings of 10 mmol/l, 13 mmol/l, and 16 mmol/l were obtained.Customer was diagnosed with hyperglycemia and also reportedly administered betahistine (anti-vertigo medication) and amoxicillin (antibiotic).Customer also underwent an mri as doctor suspected a concussion as a result of fainting.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: 8848726
• MDR Text Key: 152896720
• Report Number: 2954323-2019-05865
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• 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: 01/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2019
• 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 Weight: 118