COAG-SENSE PT/INR MONITORING METER
Report
- Report Number
- 3007507465-2026-00001
- Event Type
- Injury
- Date Received
- March 9, 2026
- Date of Event
- July 7, 2025
- Report Date
- January 6, 2026
- Manufacturer
- COAGUSENSE, INC.
- Product Code
- GJS
- PMA / PMN Number
- K212779
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IN RESPONSE TO FDA MDR REPORT # MW5182188, RECEIVED ON FEBRUARY 10, 2026, WE HAVE INITIATED OUR INVESTIGATION INTO THIS MATTER. BACKGROUND ON (B)(6) 2026, WE RECEIVED A QUESTIONABLE EMAIL FROM THE CLAIMANT, (B)(6), ENTITLED CONFIDENTIAL SETTLEMENT DEMAND - COAG-SENSE INR DEVICE FAILURE. A MEETING WAS CONVENED IMMEDIATELY AND DUE TO SEVERAL FACTORS IN THE EMAIL, WE CONCLUDED IT MAY HAVE BEEN A PHISHING OR SPAM ATTEMPT. THE EMAIL REFERENCED 8 ATTACHMENTS; HOWEVER, NOTHING WAS INCLUDED. ON (B)(6) 2026, A SIMILAR DEMAND LETTER WAS RECEIVED VIA CERTIFIED MAIL, REQUESTING A RESOLUTION OF $2.75 MILLION. LIKEWISE, THIS LETTER CONTAINED NO SUPPORTING EVIDENCE FOR THE CLAIM. COAGUSENSE CONTACTED OUR PRODUCT LIABILITY INSURANCE COMPANY, (B)(4) / A MEMBER OF PROASSURANCE GROUP DUE TO THE FINANCIAL DEMAND AND TO SHARE THE INFORMATION RECEIVED. OF NOTE, THE DEVICE IDENTIFICATION (SERIAL NUMBER) PROVIDED IN THE LETTER WAS FOR THE CURRENT METER IN USE BY THE PATIENT AND NOT THE ORIGINAL METER ATTRIBUTED TO THE ALLEGED DISCREPANCY IN (B)(6) 2025. ON (B)(6) 2026, MR. (B)(6) LEFT A VOICEMAIL SIMPLY REQUESTING ANY IDENTIFIERS OF HIS ORIGINAL PT/INR METER THAT WAS IN QUESTION OF HIS CLAIM THAT APPARENTLY HAPPENED ON (B)(6) 2025. MR. EASTMAN ALSO CALLED OUR CUSTOMER SERVICE REPRESENTATIVE ON THIS DATE, SUMMARIZED BELOW: HE HAD TOLD CUSTOMER SERVICE THAT THE METER SN# HE CURRENTLY HAS, AND PROVIDED ON THE LETTER, IS A REPLACEMENT GIVEN TO HIM BY (B)(4). HE HAD RETURNED THE ORIGINAL TO (B)(4) EARLIER. NOW HE IS LOOKING TO FIND INFORMATION FOR THAT ORIGINAL METER. CUSTOMER SERVICE TOLD HIM THAT ONLY LINCARE WILL BE ABLE TO HELP HIM WITH THAT AS METER(S) BELONGED TO THEM AND GAVE HIM THEIR CONTACT PHONE NUMBER. HE WAS PLEASANT WITH HER AND STUCK TO THE THEME AS IN HIS VM AND ENDED THE CALL THANKING HER FOR GIVING HIM LINCARE'S INFORMATION. COAGUSENSE TECHNICAL SUPPORT RESEARCHED THE COMPANY'S DATABASES FOR ANY PREVIOUS COMPLAINTS RECORDED FOR THIS PATIENT, AND NONE WERE NOTED EITHER DIRECTLY BY MR. (B)(6) OR AS A COMPLAINT ESCALATION BY (B)(4). SEVERAL MEETINGS ENSUED INTERNALLY AS WELL AS WITH INSURANCE REPRESENTATIVES AND LEGAL COUNSEL (THROUGH (B)(4)). ON (B)(6) 2026, LEGAL COUNSEL PROVIDED THREE LETTERS FOR REVIEW PRIOR TO DISTRIBUTING ACCORDINGLY, WHICH INCLUDED: 1. LITIGATION HOLD LETTER TO COAGUSENSE. 2. DRAFT PRESERVATION/SPOLIATION LETTER TO (B)(4). 3. DRAFT LETTER TO PLAINTIFF TO RESPONDING TO HIS COMPLAINT. ON THIS SAME DATE, A SECOND MDR WAS RECEIVED BY FDA, FILED BY THE SAME INDIVIDUAL. FOR REFERENCE, THIS MDR REPORT WAS ASSIGNED #MW5183057 FOR THE SAME ALLEGED DISCREPANCY BUT WITH DIFFERENT INFORMATION. RESPONSE: THE PATIENT STATED IN THIS MDR THAT "HE RELIED ON MDINR HOME INR METER/APP FOR ROUTINE INR MONITORING AND DOSING GUIDANCE WORKFLOWS." COAGUSENSE IS THE LEGAL MANUFACTURER OF THE COAG-SENSE PT/INR METER AND IS NOT ASSOCIATED WITH THE MDINR APP. THAT WEB APPLICATION IS HOSTED BY LINCARE. LINCARE IS ONE OF COAGUSENSE'S DISTRIBUTORS WHO OPERATES AS AN IDTF (INDEPENDENT DIAGNOSTIC TESTING FACILITY), PROVIDING DIAGNOSTIC TEST MATERIALS INDEPENDENT OF EITHER A PHYSICIAN'S OFFICE OR A HOSPITAL. UNDER MEDICARE THEY BILL FOR DIAGNOSTIC TESTS, NOT FOR TREATING PATIENTS, AND THEY ARE RESPONSIBLE FOR PROVIDING ALL TESTING SUPPLIES, TRAINING OF THE SELF-TESTER, AND COLLECTING TEST RESULTS TO CONVEY TO TREATING PHYSICIANS AT A FREQUENCY DECIDED PER THEIR PRESCRIPTION. THEY ARE THE OWNERS OF THE DEVICES SHIPPED TO THEM AND MUST COMPLY WITH TRACEABILITY AND OTHER STANDARDS UNDER MEDICARE REQUIREMENTS. THE PATIENT ALSO STATES THAT A "REVIEW OF HOME INR READINGS AROUND THE EVENT SHOWED BORDERLINE/SUB-THERAPEUTIC VALUES RELATIVE TO TARGET RANGE FOR MECHANICAL VALVE; THE APP LABELING DID NOT CLEARLY WARN OF LOW/SUB-THERAPEUTIC INR RISK." IT SHOULD BE NOTED THAT THE EVENT OCCURRED IN (B)(6) 2025, WITH THE REPORTED INCIDENT TO FDA IN (B)(6) 2026. IT IS OUR UNDERSTANDING THAT LINCARE HAD REPLACED THE ORIGINAL METER FROM THE (B)(6) 2025 EVENT WITH A REPLACEMENT METER AND WE HAVE NO INFORMATION ON THE ORIGINAL, NOR THE PATIENT STRIP LOT USED DURING THE TIME OF THIS EVENT. WE DID NOT RECEIVE THE ORIGINAL METER BACK WHEN THE INCIDENT OCCURRED FOR INVESTIGATION AND WE WERE NOT AWARE OF ANY COMPLAINTS FROM THIS PATIENT THROUGH LINCARE. ALSO STATED ABOVE, THE EVENT SHOWED "BORDERLINE/SUB-THERAPEUTIC VALUES RELATIVE TO THE TARGET RANGE FOR MECHANICAL VALVE." ALTHOUGH WE DO NOT HAVE THE INR VALUES AROUND THE EVENT, SUB-THERAPEUTIC VALUES MEANS THAT THE PATIENT'S BLOOD IS APPROACHING NORMAL VALUES AND THEY RUN A RISK OF FORMING BLOOD CLOTS. THE INR TARGET RANGE FOR THE PATIENT'S CONDITION IS TYPICALLY BETWEEN 2.0 AND 3.5. NORMAL INR VALUES (PERSON NOT ON WARFARIN THERAPY) IS APPROXIMATELY 1.0. THE BORDERLINE/SUB-THERAPEUTIC VALUES REPORTED ON THE METER MEANS THAT THE METER IS PERFORMING AS EXPECTED AND IS AN EARLY INDICATION OF THE PATIENT NOT BEING IN THE APPROPRIATE THERAPEUTIC RANGE. WITHOUT ACCESS TO THE SPECIFIC INR READINGS, DEVICE, OR STRIP LOT, COAGUSENSE CANNOT DETERMINE WHETHER THE REPORTED VALUES WERE CLINICALLY APPROPRIATE OR WHETHER ANY DEVICE MALFUNCTION OCCURRED. THE PRODUCTS PACKAGE INSERT STATES, "IF THE METER DISPLAYS QUESTIONABLE RESULTS, REPEAT THE TEST ENSURING THAT THE SAMPLE DOES NOT CONTAIN ANY AIR BUBBLES AS MENTIONED ABOVE. IF THE REPEATED TEST IS AGAIN OUTSIDE YOUR NORMAL RANGE, CONTACT YOUR HEALTHCARE PROVIDER IMMEDIATELY TO ASSIST WITH MONITORING YOUR PT/INR LEVEL TO ENSURE YOUR RESULTS ARE IN THE NORMAL RANGE." NORMAL RANGE STATED HERE MEANS THERAPEUTIC RANGE. THE PATIENT ALSO STATES, "THE APP LABELING DID NOT CLEARLY WARN OF LOW/SUB-THERAPEUTIC INR RISK." WE CANNOT SPEAK ABOUT THE APP LABELING SINCE THAT IS AN OFFERING BY LINCARE DIRECTLY AND IS NOT ASSOCIATED WITH COAGUSENSE. IN OUR OPINION, WARNING OF LOW/SUB-THERAPEUTIC INR'S SHOULD BE THE RESPONSIBILITY OF THE PATIENT'S PHYSICIAN AS THIS DEVICE IS INTENDED FOR USE BY PROPERLY SELECTED AND SUITABLY TRAINED PATIENTS ON THE ORDER OF THE TREATING PHYSICIAN. FURTHERMORE, THE MDINR WEB APPLICATION REFERENCED IN THE MDR IS OPERATED INDEPENDENTLY BY LINCARE AND IS NOT MANUFACTURED OR CONTROLLED BY COAGUSENSE. DUE TO THE CHRONOLOGY OF EVENTS AND THE INVOLVEMENT OF LEGAL COUNSEL ON BEHALF OF COAGUSENSE, A REQUEST HAS BEEN MADE TO THE PATIENT AND LINCARE TO OBTAIN FURTHER INFORMATION REGARDING THIS CASE. COAGUSENSE WILL UPDATE THE REPORT AS SOON AS THIS INFORMATION IS RECEIVED FOR FURTHER EVALUATION AND INVESTIGATION. COAGUSENSE WILL ALSO PROVIDE A RESPONSE TO THE SECOND MDR, # MW5183057, INITIATED BY THIS SAME PATIENT, WITH ADDITIONAL INFORMATION WHEN RECEIVED.
IN RESPONSE TO FDA MDR REPORT # MW5182188, RECEIVED ON (B)(6) 2026, WE HAVE INITIATED OUR INVESTIGATION INTO THIS MATTER. BACKGROUND ON (B)(6) 2026, WE RECEIVED A QUESTIONABLE EMAIL FROM THE CLAIMANT, (B)(6), ENTITLED CONFIDENTIAL SETTLEMENT DEMAND - COAG-SENSE INR DEVICE FAILURE. A MEETING WAS CONVENED IMMEDIATELY AND DUE TO SEVERAL FACTORS IN THE EMAIL, WE CONCLUDED IT MAY HAVE BEEN A PHISHING OR SPAM ATTEMPT. THE EMAIL REFERENCED 8 ATTACHMENTS; HOWEVER, NOTHING WAS INCLUDED. ON (B)(6) 2026, A SIMILAR DEMAND LETTER WAS RECEIVED VIA CERTIFIED MAIL, REQUESTING A RESOLUTION OF $2.75 MILLION. LIKEWISE, THIS LETTER CONTAINED NO SUPPORTING EVIDENCE FOR THE CLAIM. COAGUSENSE CONTACTED OUR PRODUCT LIABILITY INSURANCE COMPANY, MEDMARC / A MEMBER OF PROASSURANCE GROUP DUE TO THE FINANCIAL DEMAND AND TO SHARE THE INFORMATION RECEIVED. OF NOTE, THE DEVICE IDENTIFICATION (SERIAL NUMBER) PROVIDED IN THE LETTER WAS FOR THE CURRENT METER IN USE BY THE PATIENT AND NOT THE ORIGINAL METER ATTRIBUTED TO THE ALLEGED DISCREPANCY IN (B)(6) 2025. (B)(6) 2026, MR. EASTMAN LEFT A VOICEMAIL SIMPLY REQUESTING ANY IDENTIFIERS OF HIS ORIGINAL PT/INR METER THAT WAS IN QUESTION OF HIS CLAIM THAT APPARENTLY HAPPENED ON (B)(6) 2025. MR. (B)(6) ALSO CALLED OUR CUSTOMER SERVICE REPRESENTATIVE ON THIS DATE, SUMMARIZED BELOW: HE HAD TOLD CUSTOMER SERVICE THAT THE METER SN# HE CURRENTLY HAS, AND PROVIDED ON THE LETTER, IS A REPLACEMENT GIVEN TO HIM BY LINCARE. HE HAD RETURNED THE ORIGINAL TO LINCARE EARLIER. NOW HE IS LOOKING TO FIND INFORMATION FOR THAT ORIGINAL METER. CUSTOMER SERVICE TOLD HIM THAT ONLY LINCARE WILL BE ABLE TO HELP HIM WITH THAT AS METER(S) BELONGED TO THEM AND GAVE HIM THEIR CONTACT PHONE NUMBER. HE WAS PLEASANT WITH HER AND STUCK TO THE THEME AS IN HIS VM AND ENDED THE CALL THANKING HER FOR GIVING HIM LINCARE'S INFORMATION. COAGUSENSE TECHNICAL SUPPORT RESEARCHED THE COMPANY'S DATABASES FOR ANY PREVIOUS COMPLAINTS RECORDED FOR THIS PATIENT, AND NONE WERE NOTED EITHER DIRECTLY BY MR. (B)(6) OR AS A COMPLAINT ESCALATION BY LINCARE. SEVERAL MEETINGS ENSUED INTERNALLY AS WELL AS WITH INSURANCE REPRESENTATIVES AND LEGAL COUNSEL (THROUGH MEDMARC). ON (B)(6) 2026, LEGAL COUNSEL PROVIDED THREE LETTERS FOR REVIEW PRIOR TO DISTRIBUTING ACCORDINGLY, WHICH INCLUDED: 1. LITIGATION HOLD LETTER TO COAGUSENSE. 2. DRAFT PRESERVATION/SPOLIATION LETTER TO LINCARE. 3. DRAFT LETTER TO PLAINTIFF TO RESPONDING TO HIS COMPLAINT. ON THIS SAME DATE, A SECOND MDR WAS RECEIVED BY FDA, FILED BY THE SAME INDIVIDUAL. FOR REFERENCE, THIS MDR REPORT WAS ASSIGNED #MW5183057 FOR THE SAME ALLEGED DISCREPANCY BUT WITH DIFFERENT INFORMATION. RESPONSE THE PATIENT STATED IN THIS MDR THAT "HE RELIED ON MDINR HOME INR METER/APP FOR ROUTINE INR MONITORING AND DOSING GUIDANCE WORKFLOWS." COAGUSENSE IS THE LEGAL MANUFACTURER OF THE COAG-SENSE PT/INR METER AND IS NOT ASSOCIATED WITH THE MDINR APP. THAT WEB APPLICATION IS HOSTED BY LINCARE. LINCARE IS ONE OF COAGUSENSE'S DISTRIBUTORS WHO OPERATES AS AN IDTF (INDEPENDENT DIAGNOSTIC TESTING FACILITY), PROVIDING DIAGNOSTIC TEST MATERIALS INDEPENDENT OF EITHER A PHYSICIAN'S OFFICE OR A HOSPITAL. UNDER MEDICARE THEY BILL FOR DIAGNOSTIC TESTS, NOT FOR TREATING PATIENTS, AND THEY ARE RESPONSIBLE FOR PROVIDING ALL TESTING SUPPLIES, TRAINING OF THE SELF-TESTER, AND COLLECTING TEST RESULTS TO CONVEY TO TREATING PHYSICIANS AT A FREQUENCY DECIDED PER THEIR PRESCRIPTION. THEY ARE THE OWNERS OF THE DEVICES SHIPPED TO THEM AND MUST COMPLY WITH TRACEABILITY AND OTHER STANDARDS UNDER MEDICARE REQUIREMENTS. THE PATIENT ALSO STATES THAT A "REVIEW OF HOME INR READINGS AROUND THE EVENT SHOWED BORDERLINE/SUB-THERAPEUTIC VALUES RELATIVE TO TARGET RANGE FOR MECHANICAL VALVE; THE APP LABELING DID NOT CLEARLY WARN OF LOW/SUB-THERAPEUTIC INR RISK." IT SHOULD BE NOTED THAT THE EVENT OCCURRED IN (B)(6) 2025, WITH THE REPORTED INCIDENT TO FDA IN (B)(6) 2026. IT IS OUR UNDERSTANDING THAT LINCARE HAD REPLACED THE ORIGINAL METER FROM THE (B)(6) 2025 EVENT WITH A REPLACEMENT METER AND WE HAVE NO INFORMATION ON THE ORIGINAL, NOR THE PATIENT STRIP LOT USED DURING THE TIME OF THIS EVENT. WE DID NOT RECEIVE THE ORIGINAL METER BACK WHEN THE INCIDENT OCCURRED FOR INVESTIGATION AND WE WERE NOT AWARE OF ANY COMPLAINTS FROM THIS PATIENT THROUGH LINCARE. ALSO STATED ABOVE, THE EVENT SHOWED "BORDERLINE/SUB-THERAPEUTIC VALUES RELATIVE TO THE TARGET RANGE FOR MECHANICAL VALVE." ALTHOUGH WE DO NOT HAVE THE INR VALUES AROUND THE EVENT, SUB-THERAPEUTIC VALUES MEANS THAT THE PATIENT'S BLOOD IS APPROACHING NORMAL VALUES AND THEY RUN A RISK OF FORMING BLOOD CLOTS. THE INR TARGET RANGE FOR THE PATIENT'S CONDITION IS TYPICALLY BETWEEN 2.0 AND 3.5. NORMAL INR VALUES (PERSON NOT ON WARFARIN THERAPY) IS APPROXIMATELY 1.0. THE BORDERLINE/SUB-THERAPEUTIC VALUES REPORTED ON THE METER MEANS THAT THE METER IS PERFORMING AS EXPECTED AND IS AN EARLY INDICATION OF THE PATIENT NOT BEING IN THE APPROPRIATE THERAPEUTIC RANGE. WITHOUT ACCESS TO THE SPECIFIC INR READINGS, DEVICE, OR STRIP LOT, COAGUSENSE CANNOT DETERMINE WHETHER THE REPORTED VALUES WERE CLINICALLY APPROPRIATE OR WHETHER ANY DEVICE MALFUNCTION OCCURRED. THE PRODUCTS PACKAGE INSERT STATES, "IF THE METER DISPLAYS QUESTIONABLE RESULTS, REPEAT THE TEST ENSURING THAT THE SAMPLE DOES NOT CONTAIN ANY AIR BUBBLES AS MENTIONED ABOVE. IF THE REPEATED TEST IS AGAIN OUTSIDE YOUR NORMAL RANGE, CONTACT YOUR HEALTHCARE PROVIDER IMMEDIATELY TO ASSIST WITH MONITORING YOUR PT/INR LEVEL TO ENSURE YOUR RESULTS ARE IN THE NORMAL RANGE." NORMAL RANGE STATED HERE MEANS THERAPEUTIC RANGE. THE PATIENT ALSO STATES, "THE APP LABELING DID NOT CLEARLY WARN OF LOW/SUB-THERAPEUTIC INR RISK." WE CANNOT SPEAK ABOUT THE APP LABELING SINCE THAT IS AN OFFERING BY LINCARE DIRECTLY AND IS NOT ASSOCIATED WITH COAGUSENSE. IN OUR OPINION, WARNING OF LOW/SUB-THERAPEUTIC INR'S SHOULD BE THE RESPONSIBILITY OF THE PATIENT'S PHYSICIAN AS THIS DEVICE IS INTENDED FOR USE BY PROPERLY SELECTED AND SUITABLY TRAINED PATIENTS ON THE ORDER OF THE TREATING PHYSICIAN. FURTHERMORE, THE MDINR WEB APPLICATION REFERENCED IN THE MDR IS OPERATED INDEPENDENTLY BY LINCARE AND IS NOT MANUFACTURED OR CONTROLLED BY COAGUSENSE. DUE TO THE CHRONOLOGY OF EVENTS AND THE INVOLVEMENT OF LEGAL COUNSEL ON BEHALF OF COAGUSENSE, A REQUEST HAS BEEN MADE TO THE PATIENT AND LINCARE TO OBTAIN FURTHER INFORMATION REGARDING THIS CASE. COAGUSENSE WILL UPDATE THE REPORT AS SOON AS THIS INFORMATION IS RECEIVED FOR FURTHER EVALUATION AND INVESTIGATION. COAGUSENSE WILL ALSO PROVIDE A RESPONSE TO THE SECOND MDR, # MW5183057, INITIATED BY THIS SAME PATIENT, WITH ADDITIONAL INFORMATION WHEN RECEIVED. THE FOLLOWING TEXT IS THE SUMMARY OF THE MANUFACTURER'S (COAGUSENSE, INC.) INVESTIGATION AS A FOLLOW-UP TO THE INITIAL EMDR INFORMATION SUBMITTED ABOVE: LINCARE ACKNOWLEDGED RECEIPT OF THE LETTER ENTITLED, EVIDENCE PRESERVATION REQUEST FOR COAG-SENSE PT2 MONITOR, FROM LEGAL COUNSEL, RONALD P. HERBERT, ESQ. ON BEHALF OF COAGUSENSE, ON (B)(6) 2026. IN THEIR RESPONSE BY THEIR LEGAL COUNSEL, IT IS STATED, "THE MONITOR THAT WAS PROVIDED TO MR. (B)(6) BORE SERIAL NUMBER (B)(6) AND IT WAS RETURNED TO LINCARE ON (B)(6) 2025. LINCARE IS NO LONGER IN POSSESSION OF THE MONITOR AS IT WAS DESTROYED UPON RETURN IN THE DUE COURSE OF BUSINESS. TO MY KNOWLEDGE, LINCARE WAS NOT AWARE OF ANY ALLEGATIONS MADE OR LEGAL ACTION PENDING AT THE TIME THE MONITOR WAS DESTROYED." BASED ON THIS INFORMATION, COAGUSENSE WAS UNABLE TO INVESTIGATE ANY ISSUES WITH THIS PARTICULAR METER NOR WERE WE PROVIDED WITH ANY RESULTS, TRENDS OR ANY OTHER INFORMATION. COAGUSENSE MAINTAINS AN ESTABLISHED COMPLAINT HANDLING PROCEDURE THAT INCLUDES DUE DILIGENCE REVIEW OF APPLICABLE BATCH RECORDS AND ROUTINE TRENDING OF QUALITY EVENTS (E.G., NONCONFORMANCES, CAPAS, COMPLAINTS, AND ADVERSE EVENTS) TO IDENTIFY RECURRING, SYSTEMIC, AND/OR HIGH-RISK ISSUES THAT MAY REQUIRE CORRECTIVE ACTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, COAGUSENSE WILL RE-OPEN AND FURTHER ASSESS THIS EVENT IN ACCORDANCE WITH THESE PROCEDURES. AT THIS TIME, BASED ON THE INFORMATION AVAILABLE, THIS EVENT IS CONSIDERED CLOSED.
PATIENT WITH MECHANICAL/PROSTHETIC AORTIC VALVE ON LONG-TERM WARFARIN RELIED ON MDINR HOME INR METER/APP FOR ROUTINE INR MONITORING AND DOSING GUIDANCE WORKFLOW. ON (B)(6) 2025, PATIENT SUFFERED ISCHEMIC EMBOLIC STROKE AND WAS HOSPITALIZED. REVIEW OF HOME INR READINGS AROUND THE EVENT SHOWED BORDERLINE/SUB-THERAPEUTIC VALUES RELATIVE TO TARGET RANGE FOR MECHANICAL VALVE; THE APP LABELING DID NOT CLEARLY WARN OF LOW/SUB-THERAPEUTIC INR RISK. AFTER THE STROKE, MDINR INITIATED TROUBLESHOOTING/VERIFICATION STEPS VIA MULTIPLE PHONE CALLS THROUGH INR CLINIC NURSE, PROVIDED CALIBRATED TEST STRIPS (SHIPMENT DATED (B)(6) 2025), AND LATER REPLACED THE INR METER (SHIPMENT DATED (B) (6) 2025). VENOUS LAB COMPARISON TESTING WAS DISCUSSED BUT COULD NOT BE PERFORMED AT THE (B)(6) CLINIC. CONCERN IS POTENTIAL DEVICE/APP FAILURE OR INADEQUATE WARNING/ESCALATION FOR LOW INR IN A HIGH-RISK MECHANICAL VALVE PATIENT, CONTRIBUTING TO ANTICOAGULATION FAILURE AND EMBOLIC STROKE.
PATIENT WITH MECHANICAL/PROSTHETIC AORTIC VALVE ON LONG-TERM WARFARIN RELIED ON MDINR HOME INR METER/APP FOR ROUTINE INR MONITORING AND DOSING GUIDANCE WORKFLOW. ON (B)(6) 2025, PATIENT SUFFERED ISCHEMIC EMBOLIC STROKE AND WAS HOSPITALIZED. REVIEW OF HOME INR READINGS AROUND THE EVENT SHOWED BORDERLINE/SUB-THERAPEUTIC VALUES RELATIVE TO TARGET RANGE FOR MECHANICAL VALVE; THE APP LABELING DID NOT CLEARLY WARN OF LOW/SUB-THERAPEUTIC INR RISK. AFTER THE STROKE, MDINR INITIATED TROUBLESHOOTING/VERIFICATION STEPS VIA MULTIPLE PHONE CALLS THROUGH INR CLINIC NURSE, PROVIDED CALIBRATED TEST STRIPS (SHIPMENT DATED (B)(6) 2025), AND LATER REPLACED THE INR METER (SHIPMENT DATED (B) (6) 2025). VENOUS LAB COMPARISON TESTING WAS DISCUSSED BUT COULD NOT BE PERFORMED AT THE INR CLINIC. CONCERN IS POTENTIAL DEVICE/APP FAILURE OR INADEQUATE WARNING/ESCALATION FOR LOW INR IN A HIGH-RISK MECHANICAL VALVE PATIENT, CONTRIBUTING TO ANTICOAGULATION FAILURE AND EMBOLIC STROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 606260 | COAG-SENSE PT/INR MONITORING METER | TEST, TIME, PROTHROMBIN | GJS | COAGUSENSE, INC. | 200107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male | Life Threatening| O| H | 2X MEDICATION NAME: MOUNJARO (TIRZEPATIDE).| 2X MEDICATION NAME: MOUNJARO (TIRZEPATIDE).| CALCIUM.| CALCIUM.| METOPROLOL 100MG.| METOPROLOL 100MG.| VITAMIN D.| VITAMIN D.| WARFARIN 37MG.| WARFARIN 37MG. |