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

Model Number 70805-70

Device Problem No Device Output (1435)

Patient Problems Chest Pain (1776); Hyperglycemia (1905); Loss of consciousness (2418)

Event Date 08/23/2019

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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported being unable to test due to the adc blood glucose meter shutting off after a blood sample was applied.On (b)(6) 2019, customer experienced chest pain and was seen at the hospital where a reading of 500 mg/dl was obtained which was higher than her typical blood glucose level of 150 mg/dl or lower.Customer further reported that she lost consciousness while at the hospital and was treated with unspecified dose of insulin injection and oral insulin before she was discharged on (b)(6) 2019.There was no report of death or permanent injury 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 there was no indication that the product did not meet specifications.Dhrs for the freestyle lite meter was reviewed.The dhrs showed the freestyle lite meter 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 being unable to test due to the adc blood glucose meter shutting off after a blood sample was applied.On (b)(6)2019, customer experienced chest pain and was seen at the hospital where a reading of 500 mg/dl was obtained which was higher than her typical blood glucose level of 150 mg/dl or lower.Customer further reported that she lost consciousness while at the hospital and was treated with unspecified dose of insulin injection and oral insulin before she was discharged on (b)(6)2019 or (b)(6)2019.There was no report of death or permanent injury 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: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644472
• MDR Report Key: 9084836
• MDR Text Key: 159077308
• Report Number: 2954323-2019-07253
• 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,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• 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: 01/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 81