MAUDE Adverse Event Report: COAGUSENSE, INC. COAG-SENSE; PROTHROMBIN TIME (PT)/INR MONITORING SYSTEM

Model Number 200221

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problem Stroke/CVA (1770)

Event Date 06/07/2023

Event Type  Injury  

Event Description

See initial user report medwatch report (mw5118699).

Manufacturer Narrative

In response to mdr report # mw5118699, we have conducted our initial investigation into this matter and offer the following information as of this date.On (b)(6)2023, technical support received a call from the mother of the patient, stating that her son was in the hospital and due to be released the following day.She had a concern of the accuracy of the meter in comparison to lab results and was requesting a replacement pt/inr meter.Case # (b)(4) was opened internally at coagusense, the legal manufacturer of the pt/inr meter in question.Immediately, the patients distributor/patient management company, lincare, was informed and they confirmed that the meter would be replaced.According to the report, the patient has been on warfarin since 2022 (specific timeline unknown at this time), compliant with taking their medications and testing.There have been no previous complaints prior to the described event.The patient's therapeutic range was listed as 2.0 to 3.0 inr.The first issue stated was that the patient was tested in the hospital and a comparison test was conducted on the pt/inr meter within 2 minutes of one another.The lab resulted in a 3.4 inr, while the meter resulted in 2.6 inr.There are missing details from the sequence of events reported and the company is attempting to obtain further information from either lincare or directly from the patients mother.In review of other inr values provided in the report, with both the coagusense pt/inr meter and the hospital, that seem to correlate with one another.Of greater significance, as reported, 5 days prior to the results shared above, the patient obtained an inr value of 1.4 on the coagusense pt/inr meter at 9:35 am.5 hours later, at approximately 1:46 pm, the patient had stroke/seizure symptoms for 90 minutes.It is stated that the patient's hematologist adjusted the warfarin dose, but the sequence and time of events of this day are unknown.Based on this specific result, 1.4 inr, this level for a patient on warfarin means that their blood is approaching normal values and they run a risk of forming blood clots.This is a red flag and the test should have been repeated as stated in the user's manual to confirm this result.Below are excerpts from two sources verifying that inr's below the therapeutic range could indicate a medical situation.With a low inr, below about 1.5 to 2.0 if you're taking blood thinners, you may be more prone to throwing clots.Which could result in stroke, pulmonary embolisms, deep vein thrombosis, heart attacks.But there are no indications that there is a problem until it happens.Source: www.Cardiofiles.Net.Warfarin is used to prevent blood clots that cause strokes, heart attacks, or other life-threatening conditions.If the dose of warfarin is too small, the inr will be low, and a patient may get a blood clot.If the dose is too large, the inr will be high, and a patient may develop a bleeding problem.In most cases, an inr between 2 and 3 indicates that the warfarin dose is about right.In one large study,1 the risk of stroke caused by a blood clot increased 3 to 4 times when the inr was between 1.4 and 1.7 (not enough warfarin).In the same study, the risk of stroke caused by bleeding increased [?]12 times when the inr was >4.5 (too much warfarin).Several factors can cause the inr test to be inaccurate, regardless of whether a self-testing device or laboratory is used.It is always reasonable to repeat the test if the results are different than expected.A repeat test may be done by using a fresh fingerstick and a point-of-care device, or the repeat value may be measured by the traditional laboratory method.Source: www.Ahajournals.Org.In review of the pt/inr patient test strips referenced, lot # 220382, no anomalies were noted in the associated batch record.A total of (b)(4) were manufactured, meeting finished goods specifications including qc testing and qa release.Lot # 220382 was manufactured in late november 2022, with final release in january 2023.In addition, retain product was further tested according to qc test requirements, and results were well within the acceptable range for 3 levels of controls.Finally, a review was conducted of any associated complaints from this lot number, and only 3 complaints have been recorded to date, all for technique related issues that were appropriately corrected at the time of the inquiries.We are currently requesting from lincare the return of the pt/inr meter in question and any trend data they have for this particular patient test strip lot.We will update our files once any additional information if received.

• Brand Name: COAG-SENSE
• Type of Device: PROTHROMBIN TIME (PT)/INR MONITORING SYSTEM
• Manufacturer (Section D): COAGUSENSE, INC.; 48377 fremont blvd., ste 113; fremont CA 94538
• Manufacturer (Section G): COAGUSENSE, INC.; 48377 fremont blvd., ste. 113; fremont CA 94538
• Manufacturer Contact: innetta walker ; 48377 fremont blvd., ste 113; fremont, CA 94538 ; 5103358514
• MDR Report Key: 17667618
• MDR Text Key: 322477905
• Report Number: 3007507465-2023-00001
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00861900000381
• UDI-Public: (01)00861900000381
• Combination Product (y/n): N
• PMA/PMN Number: K183255
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 200221
• Device Catalogue Number: 03P70-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PATIENT TEST STRIP, SINGLE USE, LOT NUMBER 220382
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male