Dade® Innovin® 10873567Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00630414023489), received between Feb 20, 2018 and Dec 30, 2025 — classified as 30 malfunctions.

The most frequently reported specific device problem is “High Test Results” (18 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION THAT THE INR AND THE ASSOCIATED PT.SEC DETERMINATIONS OF A PATIENT SAMPLE PERFORMED WITH DADE INNOVIN ON CS-2500 S/N (B)(6) WERE FALSELY ELEVATED COMPARED TO REPEAT TESTING ON CS-5100 S/N (B)(6) AND THE CLINICAL PICTURE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920619 ↗
• MalfunctionDec 2, 2022High Test Results; High Test Results

  THREE FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS AND THREE FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-620 SYSTEM USING DADE INNOVIN REAGENT. A HIGH INR RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE PATIENT WAS REDRAWN AND WAS RERUN FOR PT AND INR, RECOVERING LOWER. THE LOWER RESULTS WERE IN LINE WITH THE PATIENT'S HOME METER. THE LOWER INR RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED PT AND INR RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15904526 ↗
• MalfunctionJun 3, 2022High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-660 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS THEN REPEATED TWO TIMES FOR PT AND INR, RECOVERING LOWER. THE LOWER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PT AND INR RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14595326 ↗
• MalfunctionFeb 17, 2022High Test Results; High Test Results

  A NON-NUMERIC PROTHROMBIN TIME (PT) RESULT FLAGGED WITH A "NO COAGULATION" ERROR FLAG WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-660 SYSTEM USING DADE INNOVIN REAGENT. THE SAMPLE WAS REPEATED FOR PT ON THE SAME SYSTEM WITH THE SAME REAGENT, AGAIN GIVING A NON-NUMERIC RESULT FLAGGED WITH A "NO COAGULATION" ERROR FLAG. THE SAMPLE WAS THEN REPEATED FOR PT ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING FALSELY ELEVATED. THE SAMPLE WAS THEN REPEATED FOR PT ON THE SAME SYSTEM WITH THE SAME REAGENT, GIVING A NON-NUMERIC RESULT FLAGGED WITH A "NO COAGULATION" ERROR FLAG. THE SAMPLE WAS THEN REPEATED FOR PT ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING LOWER. THE SAMPLE WAS THEN REPEATED FOR PT ON THE SAME SYSTEM WITH THE SAME REAGENT, RECOVERING LOWER. THE SAMPLE WAS THEN SENT TO AN ALTERNATE HOSPITAL TO BE RUN FOR PT AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR). THE PT RESULT RECOVERED LOWER. THE PT AND INR RESULTS OBTAINED AT THE ALTERNATE HOSPITAL WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552450 ↗
• MalfunctionAug 24, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-660 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME PATIENT SAMPLE WAS REPEATED FOR PT TWO MORE TIMES THAT DAY, RECOVERING LOWER THAN THE INITIAL RESULT. THE SAMPLE WAS THEN REMIXED AND RESPUN, AND WAS REPEATED TWO MORE TIMES FOR PT, RECOVERING LOWER. THE PATIENT WAS REDRAWN THAT DAY, AND THE REDRAWN SAMPLE WAS RUN FOR PT, MATCHING THE LOWER RESULTS OBTAINED AFTER REMIXING AND RESPINNING THE INITIAL SAMPLE. THIS RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359826 ↗
• MalfunctionMay 7, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-2500 SYSTEM USING DADE INNOVIN REAGENT. THE SAMPLE WAS AUTOMATICALLY REPEATED FOR PT AND INR, RECOVERING LOWER, BUT THE RESULTS WERE STILL FALSELY ELEVATED. THE AUTOMATIC REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RETESTED TWICE FOR PT AND INR ON THE SAME SYSTEM, RECOVERING LOWER. THE LOWER PT AND INR RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE SAMPLE WAS THEN REPEATED FOR PT AND INR ON A SYSMEX CA-1500 SYSTEM, CONFIRMING THE LOWER REPEAT RESULTS OBTAINED ON THE SYSMEX CS-2500 SYSTEM. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11790885 ↗
• MalfunctionMar 23, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT AND A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-660 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. PRIOR TO OBTAINING THE DISCORDANT RESULTS, THE PATIENT SAMPLE WAS RUN FOR PT AND INR, GENERATING A "NO COAGULATION" ERROR AND NO NUMERIC RESULTS. AFTER THE PHYSICIAN(S) QUESTIONED THE RESULTS, THE PATIENT WAS REDRAWN, AND THE REDRAWN SAMPLE WAS RUN FOR PT AND INR, RECOVERING LOWER. THE FIRST SAMPLE WAS THEN REPEATED FOR PT AND INR, ALSO RECOVERING LOWER. BOTH THE FIRST SAMPLE AND THE REDRAWN SAMPLE WERE THEN RUN FOR PT AND INR ON AN ALTERNATE SYSMEX CA-660 SYSTEM, ALSO RECOVERING LOWER. THE PT INR RESULTS OBTAINED FROM THE REDRAWN SAMPLE ON THE ALTERNATE SYSMEX CA-660 SYSTEM WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PT AND INR RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11557268 ↗
• MalfunctionFeb 26, 2021High Test Results; High Test Results

  TWO DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-620 SYSTEM USING DADE INNOVIN REAGENT. PRIOR TO OBTAINING THE DISCORDANT RESULTS, THE SAMPLE WAS RUN TWICE FOR PT, GENERATING NO COAGULATION ERRORS WITHOUT NUMERIC RESULTS. NONE OF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). AFTER OBTAINING THE DISCORDANT RESULTS, THE SAMPLE WAS TRANSFERRED INTO A SAMPLE CUP AND REPEATED FOR PT, RESULTING LOWER. A NEW SAMPLE FROM THE SAME PATIENT WAS THEN DRAWN AND WAS RUN FOR PT, ALSO RESULTING LOWER. THE REPEAT RESULT FROM THE REDRAWN SAMPLE WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11385932 ↗
• MalfunctionJan 6, 2021High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES FROM THE SAME PATIENT OVER SEVERAL DAYS ON A SYSMEX CS-2500 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT, FALSELY ELEVATED RESULTS WERE GENERATED AFTER THE PATIENT BEGAN RECEIVING VITAMIN K THERAPY. PRIOR TO RECEIVING VITAMIN K THERAPY, THE PATIENT HAD BEEN TESTED FOR PT AND INR USING THE SAME SYSTEM AND REAGENT, RECOVERING ACCEPTABLY. ON THE SECOND DAY OF RECEIVING VITAMIN K THERAPY, A DISCORDANT, FALSELY ELEVATED PT RESULT AND A DISCORDANT FALSELY ELEVATED INR RESULT WERE GENERATED AND REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. A NEW SAMPLE FROM THE SAME PATIENT WAS THEN RUN IN MICRO MODE, RECOVERING LOWER. THE FOLLOWING DAY, ANOTHER SAMPLE FROM SAME PATIENT WAS RUN FOR PT AND INR, BOTH RECOVERING HIGH. ON THE SAME DAY, ANOTHER SAMPLE FROM THE SAME PATIENT WAS RUN FOR PT AND INR USING A NON-SIEMENS SYSTEM AND A NON-SIEMENS REAGENT, RESULTING LOWER. THE NEXT DAY, A NEW SAMPLE FROM THE SAME PATIENT WAS RUN ON THE SYSMEX CS-2500 SYSTEM USING DADE INNOVIN REAGENT, RECOVERING HIGH. THE FOLLOWING DAY, AFTER ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11125935 ↗
• MalfunctionJan 6, 2021High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES FROM THE SAME PATIENT OVER SEVERAL DAYS ON A SYSMEX CS-2500 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT, FALSELY ELEVATED RESULTS WERE GENERATED AFTER THE PATIENT BEGAN RECEIVING VITAMIN K THERAPY. PRIOR TO RECEIVING VITAMIN K THERAPY, THE PATIENT HAD BEEN TESTED FOR PT AND INR USING THE SAME SYSTEM AND REAGENT, RECOVERING ACCEPTABLY. ON THE SECOND DAY OF RECEIVING VITAMIN K THERAPY, A DISCORDANT, FALSELY ELEVATED PT RESULT AND A DISCORDANT FALSELY ELEVATED INR RESULT WERE GENERATED AND REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. A NEW SAMPLE FROM THE SAME PATIENT WAS THEN RUN IN MICRO MODE, RECOVERING LOWER. THE FOLLOWING DAY, ANOTHER SAMPLE FROM SAME PATIENT WAS RUN FOR PT AND INR, BOTH RECOVERING HIGH. ON THE SAME DAY, ANOTHER SAMPLE FROM THE SAME PATIENT WAS RUN FOR PT AND INR USING A NON-SIEMENS SYSTEM AND A NON-SIEMENS REAGENT, RESULTING LOWER. THE NEXT DAY, A NEW SAMPLE FROM THE SAME PATIENT WAS RUN ON THE SYSMEX CS-2500 SYSTEM USING DADE INNOVIN REAGENT, RECOVERING HIGH. THE FOLLOWING DAY, AFTER ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11125889 ↗
• MalfunctionJan 6, 2021High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES FROM THE SAME PATIENT OVER SEVERAL DAYS ON A SYSMEX CS-2500 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT, FALSELY ELEVATED RESULTS WERE GENERATED AFTER THE PATIENT BEGAN RECEIVING VITAMIN K THERAPY. PRIOR TO RECEIVING VITAMIN K THERAPY, THE PATIENT HAD BEEN TESTED FOR PT AND INR USING THE SAME SYSTEM AND REAGENT, RECOVERING ACCEPTABLY. ON THE SECOND DAY OF RECEIVING VITAMIN K THERAPY, A DISCORDANT, FALSELY ELEVATED PT RESULT AND A DISCORDANT FALSELY ELEVATED INR RESULT WERE GENERATED AND REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. A NEW SAMPLE FROM THE SAME PATIENT WAS THEN RUN IN MICRO MODE, RECOVERING LOWER. THE FOLLOWING DAY, ANOTHER SAMPLE FROM SAME PATIENT WAS RUN FOR PT AND INR, BOTH RECOVERING HIGH. ON THE SAME DAY, ANOTHER SAMPLE FROM THE SAME PATIENT WAS RUN FOR PT AND INR USING A NON-SIEMENS SYSTEM AND A NON-SIEMENS REAGENT, RESULTING LOWER. THE NEXT DAY, A NEW SAMPLE FROM THE SAME PATIENT WAS RUN ON THE SYSMEX CS-2500 SYSTEM USING DADE INNOVIN REAGENT, RECOVERING HIGH. THE FOLLOWING DAY, AFTER ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11125885 ↗
• MalfunctionJan 6, 2021High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES FROM THE SAME PATIENT OVER SEVERAL DAYS ON A SYSMEX CS-2500 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT, FALSELY ELEVATED RESULTS WERE GENERATED AFTER THE PATIENT BEGAN RECEIVING VITAMIN K THERAPY. PRIOR TO RECEIVING VITAMIN K THERAPY, THE PATIENT HAD BEEN TESTED FOR PT AND INR USING THE SAME SYSTEM AND REAGENT, RECOVERING ACCEPTABLY. ON THE SECOND DAY OF RECEIVING VITAMIN K THERAPY, A DISCORDANT, FALSELY ELEVATED PT RESULT AND A DISCORDANT FALSELY ELEVATED INR RESULT WERE GENERATED AND REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. A NEW SAMPLE FROM THE SAME PATIENT WAS THEN RUN IN MICRO MODE, RECOVERING LOWER. THE FOLLOWING DAY, ANOTHER SAMPLE FROM SAME PATIENT WAS RUN FOR PT AND INR, BOTH RECOVERING HIGH. ON THE SAME DAY, ANOTHER SAMPLE FROM THE SAME PATIENT WAS RUN FOR PT AND INR USING A NON-SIEMENS SYSTEM AND A NON-SIEMENS REAGENT, RESULTING LOWER. THE NEXT DAY, A NEW SAMPLE FROM THE SAME PATIENT WAS RUN ON THE SYSMEX CS-2500 SYSTEM USING DADE INNOVIN REAGENT, RECOVERING HIGH. THE FOLLOWING DAY, AFTER ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11125839 ↗
• MalfunctionOct 13, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-620 SYSTEM USING DADE INNOVIN REAGENT. PRIOR TO ANY NUMERIC PT INR RESULTS BEING OBTAINED, THE SYSTEM GENERATED FLAGGED, NON-NUMERIC RESULTS WITH "MEASUREMENT ERROR" AND "NO COAGULATION" FLAGS. THE SAMPLE WAS THEN RUN FOR PT INR USING THE PTX TEST PROTOCOL (EXTENDED PT TEST PROTOCOL), GENERATING RESULTS WITH "ANALYSIS TIME OVER" FLAGS. THE SAMPLE WAS THEN REPEATED TWO TIMES FOR PT INR, ONCE USING THE PTX PROTOCOL AND ONCE USING THE STANDARD PT PROTOCOL, EACH TIME RECOVERING LOWER. IT IS UNKNOWN WHICH RESULTS WERE CONSIDERED CORRECT, AND IT IS UNKNOWN WHICH RESULTS WERE REPORTED TO THE PHYSICIAN(S), IF ANY. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10673974 ↗
• MalfunctionOct 13, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES FROM TWO DIFFERENT PATIENTS ON A SYSMEX CA-620 SYSTEM USING DADE INNOVIN REAGENT. THE INITIAL PT INR RESULTS FOR EACH SAMPLE WERE FLAGGED WITH "ANALYSIS TIME OVER" FLAGS. THE SAMPLE FROM THE FIRST PATIENT WAS REPEATED TWO TIMES FOR PT INR USING THE PTX TEST PROTOCOL (EXTENDED PT TEST PROTOCOL), AND ONE ADDITIONAL TIME USING THE STANDARD PT PROTOCOL. THE INR CONSISTENTLY RECOVERED LOWER, BUT THE PT RECOVERED HIGHER WITH THE PTX TEST PROTOCOL AND LOWER WITH THE PT TEST PROTOCOL. THE SAMPLE FROM THE SECOND PATIENT WAS REPEATED TWO TIMES FOR PT INR USING THE PTX PROTOCOL, EACH TIME RECOVERING LOWER. IT IS UNKNOWN WHICH RESULTS WERE CONSIDERED CORRECT, AND IT IS UNKNOWN WHICH RESULTS WERE REPORTED TO THE PHYSICIAN(S), IF ANY. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10673973 ↗
• MalfunctionApr 3, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT AND A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-2500 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT RESULTS WERE FLAGGED WITH THE ERROR "UPPER REPORT LIMIT OVER". THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED BY THE PHYSICIAN(S). THE PATIENT WAS REDRAWN AND THE NEW SAMPLE WAS RUN FOR PT AND INR, BOTH RESULTING LOWER. THESE PT AND INR RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THREE DAYS LATER, BOTH THE INITIAL AND THE REDRAWN SAMPLES WERE RERUN FOR PT AND INR ON AN ALTERNATE SYSMEX CS-2500 SYSTEM. THE RESULTS MATCHED THE PT AND INR RESULTS PREVIOUSLY OBTAINED FOR THE REDRAWN SAMPLE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT AND THE DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9922656 ↗
• MalfunctionMar 31, 2020High Test Results; High Test Results

  THREE DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS AND THREE DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-620 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS SENT TO ANOTHER HOSPITAL TO BE RERUN FOR PT AND INR. THE PT AND INR BOTH RESULTED LOWER. THESE RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE SAMPLE WAS THEN SENT BACK TO THE CUSTOMER'S LAB TO BE RERUN AGAIN FOR PT AND INR. THE PT AND INR RESULTED LOWER AND MATCHED THE RESULTS FROM THE OTHER HOSPITAL. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE THREE DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS AND THREE DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9904389 ↗
• MalfunctionFeb 13, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY HIGH PT (PROTHROMBIN TIME) AND INR (INTERNATIONAL NORMALIZED RATIO) SAMPLE RESULTS WERE OBTAINED ON ONE PATIENT USING A SYSMEX CA-1500 SYSTEM AND THE DADE INNOVIN REAGENT. THE RESULTS WERE AUTO REPEATED AND THOSE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND YIELDED LOWER RESULTS. THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AS CORRECT. THE ORIGINAL SAMPLE WAS CHECKED FOR CLOTS, CENTRIFUGED AGAIN AND RETESTED RESULTING LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY HIGH PT AND INR RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9707661 ↗
• MalfunctionJan 24, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT AND A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-2500 SYSTEM USING DADE INNOVIN REAGENT. A SECOND DISCORDANT, FALSELY ELEVATED PT RESULT AND A SECOND DISCORDANT, FALSELY ELEVATED INR RESULT WERE OBTAINED AFTER THE SAME SAMPLE WAS AUTOMATICALLY REMEASURED FOR PT AND INR. THE AUTOMATICALLY REMEASURED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED BY THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED AGAIN FOR PT AND INR, RESULTING LOWER. A NEW SAMPLE FROM THE SAME PATIENT WAS THEN RUN FOR PT AND INR, ALSO RESULTING LOWER. THE PT AND INR RESULTS OBTAINED FROM THE NEW SAMPLE WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9628553 ↗
• MalfunctionOct 14, 2019Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW PROTHROMBIN TIME (PT) RESULTS WERE OBTAINED ON 12 PATIENT SAMPLES ON A SYSMEX CS-2500 SYSTEM USING THE DADE INNOVIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). QUALITY CONTROLS HAD BEEN RUN PRIOR TO PROCESSING OF PATIENT SAMPLES AND RESULTS WERE WITHIN SPECIFICATION. THE PHYSICIAN QUESTIONED THE REPORTED RESULT FOR ONE PATIENT WHO WAS REPORTED TO BE RECEIVING COUMADIN TREATMENT. THEREFORE, ALL SAMPLES FROM BETWEEN 5:00 AM AND 7:00 AM WERE REPEATED ON AN ALTERNATE SYSMEX CS-2500 SYSTEM RESULTING HIGHER, AND THESE RESULTS WERE REPORTED AS CORRECT. THE PATIENT SAMPLE THAT WAS INITIALLY QUESTIONED, WAS ALSO REPEATED ON THE ORIGINAL SYSMEX CS-2500 SYSTEM AFTER ADJUSTMENTS WERE MADE AND THE RESULT AGREED WITH THE REPEAT TESTING PERFORMED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9187087 ↗
• MalfunctionAug 27, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  FIVE DIFFERENT PROTHROMBIN TIME (PT) RESULTS AND FIVE DIFFERENT PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A SYSMEX CA-620 SYSTEM USING DADE INNOVIN REAGENT. NONE OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND IT IS UNKNOWN IF A REDRAWN SAMPLE WAS OBTAINED. IT IS UNKNOWN WHICH OF THE RESULTS ARE DISCORDANT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROTHROMBIN TIME AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8934809 ↗
• MalfunctionJun 25, 2019Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CA-1500 SYSTEM (SERIAL NUMBER: (B)(4)) USING DADE INNOVIN REAGENT (LOT NUMBER: 549701). THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED BY THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED FOR INR ON THE SAME INSTRUMENT WITH THE SAME REAGENT, RESULTING HIGHER. THE CUSTOMER THEN RAN A PRECISION STUDY ON THE INSTRUMENT, AND ALL RESULTS RECOVERED WITHIN RANGE. THE CUSTOMER THEN REMIXED AND RESPUN THE SAME PATIENT SAMPLE AND REPEATED IT AGAIN FOR INR USING THE SAME SYSTEM AND REAGENT, ALSO RESULTING HIGHER AND CONFIRMING THE INITIAL REPEAT. THE TWO REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF MEDICAL INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW INR RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8732289 ↗
• MalfunctionMar 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT IN SECONDS WITH A CORRESPONDING, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED USING DADE INNOVIN REAGENT ON A SYSMEX CA-1500 SYSTEM. THE DISCORDANT, FALSELY ELEVATED PT RESULT WITH THE CORRESPONDING INR RESULT WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR PT USING THE SAME REAGENT LOT ON ANOTHER SYSMEX CA-1500 SYSTEM, RESULTING LOWER. THE REPEAT PT RESULT IN SECONDS RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED PT/INR RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8452551 ↗
• MalfunctionMar 19, 2019Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW PROTHROMBIN TIME (PT) RESULT AND A DISCORDANT, FALSELY LOW PT INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED USING DADE INNOVIN REAGENT ON A SYSMEX CA-1500 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED FOR PT AND INR THRICE UNDER SAMPLE ID (B)(6) USING THE SAME INSTRUMENT AND THE SAME REAGENT, RESULTING HIGHER. THE FIRST REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW PT/INR RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8432741 ↗
• MalfunctionJan 10, 2019High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PT INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON A PATIENT SAMPLE, USING THE DADE INNOVIN REAGENT, ON A SYSMEX CA-1500 SYSTEM. THE SAMPLE WAS AUTOMATICALLY REPEATED USING THE SAME REAGENT AND SYSTEM, RESULTING HIGHER AND DISCORDANT, FALSELY ELEVATED. THE DISCORDANT, REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLE WAS RE-CENTRIFUGED, MIXED, AND REPEATED USING THE SAME REAGENT LOT AND SYSTEM, RESULTING LOWER. THE PATIENT WAS ALSO SENT TO A DIFFERENT LABORATORY, WHERE THE PATIENT'S BLOOD WAS REDRAWN. THE RESULT OBTAINED ON THE NEW SAMPLE WAS 3.00 INR AND THIS RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PT AND PT INR RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8233509 ↗
• MalfunctionOct 8, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PT INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A SYSMEX CA-620 SYSTEM, USING THE DADE INNOVIN REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). SAMPLE ID (B)(6) WAS RESPUN AND THEN BOTH SAMPLES WERE REPEATED ON THE SAME SYSTEM, USING THE SAME REAGENT, MULTIPLE TIMES. THE REPEAT RESULT OF 29.5 PT AND 2.98 PT INR FOR SAMPLE ID (B)(6) AND THE RESULT OF 41.7 PT AND 4.25 PT INR FOR SAMPLE ID (B)(6) WERE REPORTED, AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PT AND PT INR PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7942937 ↗