Thromborel® S 10446445Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00842768011337), received between Aug 7, 2017 and Feb 19, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “High Test Results” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY ELEVATED PT (PROTHROMBIN TIME) INR (INTERNATIONAL NORMALIZED RATIO) RESULTS OBTAINED ON FOUR (4) PATIENT SAMPLES MEASURED WITH THROMBOREL S ON THE CS-2500 INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S) BUT THEY WERE NOT QUESTIONED. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS. THE REPEATED RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PT INR RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387180 ↗
• MalfunctionJul 31, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT INCREASED INR RESULTS AND FALSELY ELEVATED PT (PROTHROMBIN TIME) SEC RESULTS OBTAINED ON PATIENT SAMPLE MEASURED WITH THROMBOREL S ON THE CS-5100 INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673114 ↗
• MalfunctionJun 24, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT INCREASED INR RESULTS AND FALSELY ELEVATED PT (PROTHROMBIN TIME) SEC RESULTS OBTAINED ON PATIENT SAMPLE MEASURED WITH THROMBOREL S ON THE CS-2500 INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22317866 ↗
• MalfunctionMar 10, 2023Low Test Results; Low Test Results

  A CUSTOMER REPORTED THAT THE LABORATORY DID NOT ENTER THE INTERNATIONAL SENSITIVITY INDEX (ISI) FOR THE THROMBOREL S REAGENT WHEN THEY INSERTED REAGENT LOT: 568123 ON THEIR SYSMEX CS-2500 SYSTEM. THEREFORE, THE SYSTEM INTERPRETED THE ISI AS 0. AS THE PROTHROMBIN TIME (PT) INTERNATIONAL NORMALIZED RATIO (INR) IS CALCULATED USING THE ISI VALUE, 21 PATIENT SAMPLES THAT WERE PROCESSED FOR PT INR USING THIS REAGENT LOT INCORRECTLY RECOVERED AS 1.00. OF THESE PATIENTS, THE CUSTOMER INDICATED THAT A PATIENT RECEIVED ENOXAPARIN SODIUM INJECTIONS AFTER THE INCORRECT RESULT WAS RELEASED, AND ANOTHER PATIENT HAD A CHANGE IN DOSAGE OF XARELTO AND WARFARIN AND EXPERIENCED DISCOMFORT AFTER THE INCORRECT RESULT WAS RELEASED. THREE DAYS LATER, THE CUSTOMER REALIZED THAT THE ISI WAS NOT ENTERED, AFTER WHICH THEY RECALCULATED THE INR RESULTS OF THE AFFECTED PATIENTS. THE RECALCULATED INR RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE PHYSICIAN(S) ADJUSTED THE PATIENTS' PRESCRIPTIONS AFTER THE CORRECT INR RESULTS WERE RELEASED AND REPORTED THAT THERE WAS NO CLINICAL IMPACT TO THE PATIENTS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT. STATEMENTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16524721 ↗
• MalfunctionNov 4, 2021High Test Results; High Test Results

  TWELVE DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A SYSMEX CS-5100 SYSTEM USING THROMBOREL S REAGENT. THE ELEVATED PT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE FOLLOWING DAY, THE PATIENT SAMPLES WERE RERUN FOR PT, 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 FALSELY ELEVATED PROTHROMBIN TIME RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751524 ↗
• MalfunctionNov 4, 2021High Test Results; High Test Results

  TWELVE DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A SYSMEX CS-5100 SYSTEM USING THROMBOREL S REAGENT. THE ELEVATED PT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE FOLLOWING DAY, THE PATIENT SAMPLES WERE RERUN FOR PT, 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 FALSELY ELEVATED PROTHROMBIN TIME RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751521 ↗
• MalfunctionDec 22, 2020High 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-2100I SYSTEM USING THROMBOREL S REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RESPUN AND WAS REPEATED FOR PT AND INR, BOTH OF WHICH RECOVERED LOWER. THE SAME SAMPLE WAS THEN REPEATED A SECOND TIME FOR PT AND INR, RECOVERING LOWER AND CONFIRMING THE LOWER RESULTS. THE INR RESULT OBTAINED FROM THE FIRST REPEAT 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) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11057689 ↗
• MalfunctionSep 24, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-2100I SYSTEM USING THROMBOREL S REAGENT. DUE TO THE HIGH RESULT, THE SAMPLE WAS RERUN FOR INR USING THE SAME SYSTEM AND SAME REAGENT, RESULTING LOWER. THE SAME SAMPLE WAS THEN REPEATED FOR INR ON A SYSMEX CS-5100 SYSTEM USING THROMBOREL S REAGENT, RESULTING LOWER. THE INITIAL DISCORDANT RESULT OBTAINED ON THE SYSMEX CS-2100I SYSTEM WAS AUTO-VALIDATED AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER INFORMED THE PHYSICIAN(S) TO DISREGARD THE FALSELY ELEVATED INR RESULT AND REQUESTED THAT ANOTHER SAMPLE FROM THE PATIENT BE OBTAINED AND RUN FOR INR. THE PATIENT WAS REDRAWN AND THE SAMPLE WAS RUN FOR INR, RESULTING LOWER AND MATCHING THE RESULT PREVIOUSLY OBTAINED ON THE SYSMEX CS-5100 SYSTEM. THIS RESULT 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 INTERNATIONAL NORMALIZED RATIO (INR) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10580966 ↗
• MalfunctionMay 18, 2020Low 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-660 SYSTEM (SERIAL NUMBER: (B)(4)) USING THROMBOREL S REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE FOLLOWING DAY, A NEW SAMPLE FROM THE SAME PATIENT WAS RUN FOR INR AT AN ALTERNATE LAB, RECOVERING HIGHER. THIS RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). TWO DAYS LATER, THE INITIAL SAMPLE FROM THE PATIENT WAS REPEATED FOR INR ON THE CUSTOMER'S ALTERNATE SYSMEX CA-660 SYSTEM (SERIAL NUMBER: (B)(4)) USING THROMBOREL S REAGENT, ALSO RECOVERING HIGHER. THIS TRIGGERED A LOOKBACK AND IT WAS FOUND THAT DISCORDANT, FALSELY LOW INR RESULTS WERE OBTAINED ON THREE ADDITIONAL PATIENT SAMPLES THAT WERE RUN THREE DAYS PRIOR ON THE LAB'S SYSMEX CA-660 SYSTEM (SERIAL NUMBER: (B)(4)) USING THROMBOREL S REAGENT. THE SAME THREE PATIENT SAMPLES WERE REPEATED FOR INR ON SYSMEX CA-660 SYSTEM (SERIAL NUMBER: (B)(4)) USING THROMBOREL S REAGENT, ALL RECOVERING HIGHER. ALL OF THE REPEAT INR RESULTS WERE CONSIDERED CORRECT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10065361 ↗
• MalfunctionMay 15, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT, AS WELL AS A DISCORDANT, FALSELY LOW PROTHROMBIN TIME PERCENT (PT%) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING THROMBOREL S REAGENT. PRIOR TO OBTAINING THE DISCORDANT RESULTS, THE SAMPLE WAS RUN FOR INR USING DADE INNOVIN REAGENT ON TWO DIFFERENT SYSMEX CS-5100 SYSTEMS (SERIAL NUMBERS: (B)(4)) BUT THE SYSTEMS DID NOT YIELD NUMERIC RESULTS AND GENERATED NO COAGULATION ERRORS. AFTER THE INITIAL DISCORDANT RESULTS WERE OBTAINED USING THROMBOREL S REAGENT, THE SAMPLE WAS REPEATED FOR INR ON SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING DADE INNOVIN REAGENT BUT THE SYSTEM DID NOT YIELD NUMERIC RESULTS AND GENERATED NO COAGULATION ERRORS. THE SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ON SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING THROMBOREL S REAGENT. THE PT AND INR RECOVERED FALSELY HIGH, AND THE PT% RECOVERED FALSELY LOW. NONE OF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, A NEW SAMPLE FROM THE SAME PATIENT WAS RUN WAS FOR PT, INR, AND PT% ON SYSMEX CS-5100 SYSTEM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10061296 ↗
• MalfunctionJan 6, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WAS OBTAINED ON A SYSMEX CS-5100 SYSTEM USING THE THROMBOREL-S REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PHYSICIAN(S) QUESTIONED THE REPORTED RESULT. THE FOLLOWING DAY, THE PHYSICIAN(S) PERFORMED A POINT OF CARE FINGER PRICK TEST AND GOT A HIGHER RESULT. ALSO THE FOLLOWING DAY, THE ORIGINAL PATIENT SAMPLE WAS REPEATED ON THE SAME SYSMEX CS-5100 SYSTEM RESULTING HIGHER. THE ORIGINAL SAMPLE WAS THEN TESTED ON AN ALTERNATE SYSMEX CS-2100 SYSTEM WHICH ALSO RESULTED HIGHER. THE HIGHER RESULTS WERE CONSIDERED AS CORRECT AND A CORRECTED REPORT WAS SUBMITTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO RESULT ON THE SYSMEX CS-5100 SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9554135 ↗
• MalfunctionNov 25, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT, A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT, AND A DISCORDANT, FALSELY LOW PROTHROMBIN TIME PERCENT (PT%) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-5100 SYSTEM USING THROMBOREL S REAGENT. PRIOR TO OBTAINING THESE DISCORDANT RESULTS, THE INITIAL INR RESULTS FOR THIS SAMPLE HAD NO COAGULATION ERROR FLAGS WHEN RUN WITH DADE INNOVIN REAGENT. AN ADDITIONAL DISCORDANT, FALSELY ELEVATED PT RESULT, AN ADDITIONAL DISCORDANT, FALSELY ELEVATED INR RESULT, AND AN ADDITIONAL DISCORDANT, FALSELY LOW PT% RESULT WERE OBTAINED WHEN THE SAME PATIENT SAMPLE WAS RERUN ON AN ALTERNATE SYSMEX CS-5100 SYSTEM USING THROMBOREL S REAGENT. THE FOLLOWING DAY, A NEW SAMPLE WAS COLLECTED FROM THE PATIENT AND WAS RUN FOR PT, INR, AND PT% USING DADE INNOVIN REAGENT. THE PT AND INR RESULTED LOWER AND THE PT% RESULTED HIGHER. THIS INR RESULT OBTAINED WITH THE DADE INNOVIN REAGENT WAS REPORTED, AS THE CORRECTED 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, THE DISCORD

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9370271 ↗
• MalfunctionNov 13, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT, A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT, AND A DISCORDANT, FALSELY LOW PROTHROMBIN TIME PERCENT (PT%) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-5100 SYSTEM USING THROMBOREL S REAGENT. PRIOR TO OBTAINING THESE DISCORDANT RESULTS, THE INITIAL INR RESULTS FOR THIS SAMPLE HAD NO COAGULATION ERROR FLAGS. AN ADDITIONAL DISCORDANT FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT, TWO DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS, AND ONE DISCORDANT, FALSELY LOW PROTHROMBIN TIME PERCENT (PT%) RESULT WERE OBTAINED ON THE SAME PATIENT SAMPLE WHEN THE SAMPLE WAS RERUN ON AN ALTERNATE SYSMEX CS-5100 SYSTEM USING DADE INNOVIN REAGENT. THE SAME SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ON THE SAME ALTERNATE SYSTEM WITH THROMBOREL S REAGENT. THE PT AND INR RESULTED LOWER AND THE PT% RESULTED HIGHER. THE SAME SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ON THE SAME ALTERNATE SYSTEM USING DADE INNOVIN REAGENT. THE PT AND INR RESULTED LOWER AND THE PT% RESULTED HIGHER THAN THE INITIAL DISCORDANT RESULTS. THE SAME SAMPLE WAS REPE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9316297 ↗
• MalfunctionAug 8, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT AND TWO DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A SYSMEX CS-5100 INSTRUMENT SERIAL NUMBER: (B)(4) USING THROMBOREL S REAGENT (LOT NUMBER: 565656). THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED TWICE FOR PT AND TWICE FOR INR, ONCE ON AN ALTERNATE SYSMEX CS-5100 INSTRUMENT SERIAL NUMBER: (B)(4) AND ONCE ON THE SAME SYSMEX CS-5100 INSTRUMENT SERIAL NUMBER: (B)(4). THE 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 DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8875650 ↗
• MalfunctionFeb 13, 2019High Test Results; Low Test Results; High Test Results; Low Test Results

  DISCORDANT, FALSELY LOW PROTHROMBIN TIME (PT), FALSELY LOW INR (INTERNATIONAL NORMALIZED RATIO) AND FALSELY ELEVATED PT % RESULTS WERE OBTAINED ON A PATIENT SAMPLE USING THROMBORELS (LOT 562877) ON A SYSMEX CS-5100 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO A PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE PATIENT WAS REDRAWN AND A NEW SAMPLE WAS TESTED ON AN ALTERNATE SYSMEX CS-5100 SYSTEM USING THE SAME REAGENT AND RESULTING HIGHER FOR PT, INR AND LOWER FOR PT %. THE RESULT OBTAINED ON THE NEW SAMPLE WAS REPORTED TO THE PHYSICIAN. THE INITIAL SAMPLE WAS REPEATED ON THE INITIAL SYSMEX CS-5100 SYSTEM AND THE RESULT CORRELATED WITH THE NEW SAMPLE RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PT, INR AND FALSELY ELEVATED PT % RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8334848 ↗
• MalfunctionSep 14, 2018High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) INTERNATIONAL NORMALIZED RATIO (INR) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-2100I SYSTEM, USING THE THROMBOREL S REAGENT. THE SAMPLE WAS REPEATED USING THE SAME SYSTEM AND REAGENT, IN EXTENDED TIME, RESULTING LOWER. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND THE PATIENT WAS ADVISED TO STOP TAKING WARFARIN MEDICATION. ON THE NEXT DAY, THE PATIENT WAS RE-DRAWN AND THE NEW SAMPLE WAS RUN ON AN ALTERNATE SYSTEM, RESULTING LOWER. THE INITIAL SAMPLE WAS ALSO REPEATED ON THE INITIAL SYSTEM USING THE SAME REAGENT LOT, RESULTING LOWER THAN THE INITIAL RESULT. THE 2ND REPEAT RESULT AND THE REDRAWN SAMPLE RESULT WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PT INR RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7878280 ↗
• MalfunctionSep 14, 2018High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND A DISCORDANT, FALSELY ELEVATED PT INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-2100I SYSTEM USING THE THROMBOREL S REAGENT. THE SAMPLE WAS REPEATED USING THE SAME SYSTEM AND REAGENT IN EXTENDED TIME, RESULTING LOWER. THE CUSTOMER REPEATED THE SAMPLE AFTER REPLACING THE LOW VOLUME REAGENT VIAL WITH A NEW THROMBOREL S REAGENT VIAL FROM THE SAME LOT. THE 2ND REPEAT RESULTS RECOVERED LOWER AND 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 PT INR RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7878258 ↗
• MalfunctionAug 10, 2018High Test Results; High Test Results

  NON-NUMERICAL PROTHROMBIN TIME (PT) AND PT INTERNATIONAL NORMALIZED RATIO (INR) RESULTS, FLAGGED WITH "NO COAGULATION", WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-2100I SYSTEM WITH THE THROMBOREL S REAGENT. THE SAMPLE WAS REPEATED ON THE SAME SYSTEM, RESULTING IN DISCORDANT, FALSELY ELEVATED PT AND PT INR RESULTS. THE DISCORDANT PT INR RESULT WAS AUTO-VALIDATED AND REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS RE-CENTRIFUGED AND REPEATED ON THE SAME SYSTEM, RESULTING LOWER. THE PATIENT'S BLOOD WAS ALSO REDRAWN AND RUN ON THE SAME SYSTEM, RESULTING LOWER. THE PT INR RESULT, OBTAINED ON THE REDRAWN SAMPLE, WAS REPORTED 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 7771855 ↗
• MalfunctionJan 19, 2018High Test Results; High Test Results

  DISCORDANT HIGH ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT), PROTHROMBIN TIME (PT), INTERNATIONAL NORMALIZED RATIO (INR), AND DERIVED FIBRINOGEN (DER FIB) PATIENT RESULTS ON ONE (1) PATIENT SAMPLE WERE GENERATED ON A SYSMEX CS-5100 ANALYZER (SN (B)(4)). THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN AS THEY DID NOT MEET THE CLINICAL HISTORY OF THE PATIENT. THE SAME PATIENT SAMPLE WAS REPEATED ON A DIFFERENT SYSMEX CS-5100 (SN (B)(4)) AND LOWER APTT, PT, INR, AND DER FIB PATIENT RESULTS WERE GENERATED. THESE RESULTS WERE REPORTED TO THE PHYSICIAN. ALL RESULTS WERE RUN ON THE SAME DAY ((B)(6) 2017) ON THE SAME PATIENT SAMPLE. THE PT /INR /DER FIB PATIENT RESULTS (INITIAL AND REPEAT) WERE GENERATED USING THROMBOREL S REAGENT AND APTT PATIENT RESULTS (INITIAL AND REPEAT) WERE GENERATED USING THE DADE ACTIN FS ACTIVATED PARTIAL THROMBOPLASTIN TIME (PTT) REAGENT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH APTT, PT, INR, AND DER FIB PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7207699 ↗
• MalfunctionDec 18, 2017Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS AND DISCORDANT, FALSELY ELEVATED PT INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON 2 PATIENT SAMPLES ON THE SYSMEX CS-2100I SYSTEM. SAMPLE (B)(6) WAS AUTOMATICALLY RERUN BY THE SYSTEM AND RERUN BY THE USER, RESULTING LOWER THAN THE INITIAL RESULTS. NONE OF THE RESULTS OBTAINED ON (B)(6) 2017 FOR (B)(6) WERE REPORTED TO THE PHYSICIAN, WHILE THE DISCORDANT PT INR RESULT WAS REPORTED FOR (B)(6). THE PHYSICIAN DID NOT QUESTION THE DISCORDANT RESULT. (B)(6) WAS ALSO RERUN ON AN ALTERNATE NON-SIEMENS (ROCHE) SYSTEM, RESULTING LOWER THAN THE INITIAL RESULT. ON THE FOLLOWING DAY, A NEW SAMPLE WAS COLLECTED FROM THE PATIENT OF (B)(6) AND RUN ON THE SAME SYSMEX CS-2100I SYSTEM, RESULTING LOWER THAN THE INITIAL RESULTS. (B)(6) WAS RERUN ON THE SAME SYSTEM, RESULTING LOWER THAN THE INITIAL RESULTS. THE RESULTS OBTAINED ON BOTH SAMPLES ON (B)(6)2017 WERE CONSIDERED TO BE CORRECT AND REPORTED TO THE PHYSICIAN(S). THE PT TEST WAS ORDERED BY THE PHYSICIAN(S) TO MONITOR THE PATIENTS' WARFARIN THERAPY. THE EXPECTED RESULTS FOR THESE PATIENTS WERE UNKNOWN SINCE THE PATIENTS' WARFARIN THERAPY DOSAGE WAS NOT PROVI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7127399 ↗
• MalfunctionAug 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROTHROMBIN TIME (PT) / INTERNATIONAL NORMALIZED RATIO (INR) INITIAL PATIENT RESULTS WERE GENERATED AND DELAYED ON THE SYSMEX CS-2100I SYSTEM. THE DELAY IN THE PT / INR INITIAL PATIENT RESULTS TO THE PHYSICIAN RESULTED IN THE PATIENT RECEIVING THEIR NORMAL DOSE OF WARFARIN WHEN IN FACT THE PATIENT'S INR WAS HIGH. THE SAME SAMPLE WAS REPEATED TWICE ON THE SAME SYSTEM WHEN THE USER DISCOVERED THE PT/INR PATIENT RESULT DELAY ON THE SYSMEX CS-2100I SYSTEM. THE REPEAT PT PATIENT RESULTS WERE 127.8 SEC AND 138.1 SEC. THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR APPROPRIATE VITAMIN K TREATMENT AND WAS RELEASED THE NEXT DAY. THERE WAS NO KNOWN NEGATIVE IMPACT OR ADVERSE HEALTH CONSEQUENCE TO THE PATIENT DUE TO THE VITAMIN K TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6770133 ↗