MAUDE Adverse Event Report: COAGUSENSE INC. COAGSENSE PT/INR MONITORING METER; TEST, TIME, PROTHROMBIN

Catalog Number 03P70-01 COAG-SENSE SELF-TEST

Device Problem Low Test Results (2458)

Patient Problem Stroke/CVA (1770)

Event Date 06/07/2023

Event Type  Injury  

Event Description

On (b)(6) during a recent hospitalization, we tested our coagsense home inr machine (using a lancet, etc) and compared the result to the hospital lab result (blood draw done by hospital staff) to see if results were comparable.32 year old patient has been using a coagsense home inr machine since the end of (b)(6) 2022 to monitor warfarin levels.Testing is done weekly by caregiver according to manufacturer's recommendations and as trained by the supplier of the machine.All samples, including on the day of hospitalization, were collected according to manufacturer's recommendations.Patient has been fully compliant with taking meds and testing since beginning warfarin in (b)(6) 2022.Hospital blood draw and coagsense machine testing on (b)(6) were done within less than 2 minutes of each other.No food or meds had been consumed in the previous 2 hours or so.Coagsense result was 2.6 (individual's target range is 2.0 to 3.0) hospital lab result was 3.4.There is a significant difference between the two results; if a patient's inr level is too high, there is an increased risk of hemorrhagic stroke and if the level is too low, there is an increased risk of ischemic/thrombotic stroke.Patient was asymptomatic immediately before and after.However, 5 days before (b)(6), the patient had 90 minutes of stroke/seizure like symptoms and the most recent inr result prior to that event was earlier that same day and inr result on home machine was 1.4 (well below target range).On (b)(6), the home inr test was performed at 9:35am, and the event began at 1:46pm (also (b)(6).The dose of warfarin was adjusted by the hematologist in response to the coagsense results.On (b)(6), warfarin had not yet been given before the event.It does not matter how often an inr machine is unreliable in order for it to pose a significant health risk.Because of significant stroke risks from incorrect results, there are significant risks to the patient's life, health and level of function.Therefore any unreliability is an unacceptable risk.Patient test strip lot # 220382, serial number of coagsense machine (b)(6) recent inr results from may/june 2023 (results prior to (b)(6) 2023 available upon request) (b)(6) 2023 2.9.Coagsense inr result (b)(6) 2023 2.7, coagsense inr result (b)(6) 2023 3.41, test done in emergency room because patient had tia (b)(6) 2023 3.48 test done by hospital staff during hospitalization post tia (b)(6) 2023 3.9, coagsense inr result (b)(6) 2023 2.0, coagsense inr result (b)(6) 2023 1.8 ,coagsense inr result (b)(6) 2023 3.18 test done in emergency room because patient had stroke, (b)(6) 2023 2.79 done by hospital staff during hospitalization post stroke; (b)(6) 2023 1.4 see notes above - patient possibly had stroke that day (b)(6) 2023 3.4 test done by hospital staff during scheduled hospitalization (this was the day/time we tested the home machine to compare values to hospital lab results) 2.6; coagsense inr result (b)(6) 2023 2.7 test done by hospital staff during scheduled hospitalization; (b)(6) 2023 2.0 test done by hospital staff during scheduled hospitalization; (b)(6) 2023 2.1 test done by hospital staff during scheduled hospitalization; (b)(6) 2023 3.0 test done by hospital staff during scheduled hospitalization; (b)(6) 2023 3.5 test done by hospital staff during scheduled hospitalization; (b)(6) 2203 2.4 test done by hospital staff during scheduled hospitalization; (b)(6) 2023 2.2 test done by hospital staff during scheduled hospitalization.Coagsense result was 2.6.Hospital lab result was 3.4.Significant difference! patient was asymptomatic immediately before and after.However, 5 days before(b)(6), patient had 90 minutes of stroke/seizure like symptoms and most recent inr result prior to that event was earlier that same day and inr result on home machine was 1.4 (well below target range).Dosing was adjusted (as always when necessary) per the hematologist's office.(though warfarin had not yet been given that day.) patient test strip lot # 220382, serial number of coagsense machine ((b)(6).

• Brand Name: COAGSENSE PT/INR MONITORING METER
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): COAGUSENSE INC.
• MDR Report Key: 17185790
• MDR Text Key: 317772165
• Report Number: MW5118699
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 03P70-01 COAG-SENSE SELF-TEST
• Device Lot Number: 220382
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2023
• Patient Sequence Number: 1
• Treatment: ASPIRIN; ATORVASTATIN; B COMPLEX VITAMINS; BENADRYL; CORLANOR; FLAXSEED OIL; FLUOXETINE; LORATADINE; MAGNESIUM MALATE; MELATONIN; MIGRELIEF; MUTLI VITAMIN; NORVASC; THEANINE; VALERIAN ROOT; VITAMIN D3; VITAMIN E; VYVANSE; WARFARIN; ZONISAMIDE
• Patient Outcome(s): Life Threatening
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White