MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LITE; BLOOD GLUCOSE MONITORING SYSTEM

Model Number 70805-70

Device Problem No Display/Image (1183)

Patient Problems Hypoglycemia (1912); Convulsion/Seizure (4406)

Event Date 07/25/2021

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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle libre meter were reviewed and the dhrs showed the freestyle lite meter passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event is unknown.The date entered in section b3 is based on the customer's report of "6 months - year ago".All pertinent information available to abbott diabetes care has been submitted.

Event Description

A display issue was reported with the adc blood glucose meter.Customer reported no test strip icon appeared on the meter display when the test strip was inserted and only a blood drop icon appeared.Customer experienced a seizure and had contact with an hcp who provided unspecified treatment for a reported diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

At this time product has not yet 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 freestyle libre meter were reviewed and the dhrs showed the freestyle lite meter passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event is unknown.The date entered in section b3 is based on the customer's report of "6 months - year ago".All pertinent information available to abbott diabetes care has been submitted.

Event Description

A display issue was reported with the adc blood glucose meter.Customer reported no test strip icon appeared on the meter display when the test strip was inserted and only a blood drop icon appeared.Customer experienced a seizure and had contact with an hcp who provided unspecified treatment for a reported diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LITE
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 13572263
• MDR Text Key: 285922791
• Report Number: 2954323-2022-05914
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00699073708052
• UDI-Public: 00699073708052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092602
• 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: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 70805-70
• Device Catalogue Number: 70805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 60 KG