Thromborel SRecalls & reported problems across all models

We found 2 models of Thromborel S by Siemens Healthcare Diagnostics Products GmbH in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Aug 7, 2017 and Feb 19, 2026 — classified as 25 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Thromborel S problems

Thromborel S models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Thromborel® S 10446445

  TEST, TIME, PROTHROMBIN
  21 reports
• Thromborel® S 10446442

  TEST, TIME, PROTHROMBIN
  4 reports

Recent Thromborel S adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionAug 24, 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 CA-660 SYSTEM USING THROMBOREL S REAGENT. PRIOR TO OBTAINING THE DISCORDANT RESULTS, THE SAMPLE WAS RUN FOR PT, INR, AND PT%, BUT THE SYSTEM DID NOT YIELD NUMERIC RESULTS AND GENERATED AN ERROR MESSAGE. AFTER THE INITIAL DISCORDANT RESULTS WERE OBTAINED, THE SAME SAMPLE WAS REPEATED FOR PT, INR, AND PT% USING THE SAME SYSTEM AND REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER. THE SAME SAMPLE WAS THEN REPEATED AGAIN FOR PT, INR, AND PT% USING THE SAME SYSTEM AND REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER. THESE FINAL PT, INR, AND PT% RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). 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 ALSO OBTAINED ON ANOTHER PATIENT SAMPLE FROM A DIFFERENT PATIENT ON THE SAME DAY ON A SYSMEX CA-660 SYSTEM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10442778 ↗
• MalfunctionAug 24, 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 CA-660 SYSTEM USING THROMBOREL S REAGENT. THE SAME SAMPLE WAS REPEATED FOR PT, INR, AND PT% USING THE SAME SYSTEM AND REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER. THE REPEAT PT, INR, AND PT% RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE SAME PATIENT SAMPLE WAS THEN RUN FOR PT, INR, AND PT% IN AN ALTERNATE TUBE ON THE SYSMEX CA-660 SYSTEM USING THROMBOREL S REAGENT, BUT THE SYSTEM DID NOT YIELD NUMERIC RESULTS AND GENERATED AN ERROR MESSAGE. THE SAME SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% USING THE SAME SYSTEM AND REAGENT. THE PT AND INR RECOVERED HIGHER AND THE PT% RECOVERED LOWER. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, A NEW SAMPLE FROM THE SAME PATIENT WAS RUN FOR INR, RECOVERING LOWER THAN THE INR RESULTS FROM THE PREVIOUS DAY. IT IS UNKNOWN IF THIS RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10442774 ↗
• MalfunctionAug 24, 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 CA-660 SYSTEM USING THROMBOREL S REAGENT. THE SAME SAMPLE WAS REPEATED FOR PT, INR, AND PT% USING THE SAME SYSTEM AND REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER. THE REPEAT PT, INR, AND PT% RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE SAME PATIENT SAMPLE WAS THEN RUN FOR PT, INR, AND PT% IN AN ALTERNATE TUBE ON THE SYSMEX CA-660 SYSTEM USING THROMBOREL S REAGENT, BUT THE SYSTEM DID NOT YIELD NUMERIC RESULTS AND GENERATED AN ERROR MESSAGE. THE SAME SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% USING THE SAME SYSTEM AND REAGENT. THE PT AND INR RECOVERED HIGHER AND THE PT% RECOVERED LOWER. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, A NEW SAMPLE FROM THE SAME PATIENT WAS RUN FOR INR, RECOVERING LOWER THAN THE INR RESULTS FROM THE PREVIOUS DAY. IT IS UNKNOWN IF THIS RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10442773 ↗
• MalfunctionAug 24, 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 CA-660 SYSTEM USING THROMBOREL S REAGENT. PRIOR TO OBTAINING THE DISCORDANT RESULTS, THE SAMPLE WAS RUN FOR PT, INR, AND PT%, BUT THE SYSTEM DID NOT YIELD NUMERIC RESULTS AND GENERATED AN ERROR MESSAGE. AFTER THE INITIAL DISCORDANT RESULTS WERE OBTAINED, THE SAME SAMPLE WAS REPEATED FOR PT, INR, AND PT% USING THE SAME SYSTEM AND REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER. THE SAME SAMPLE WAS THEN REPEATED AGAIN FOR PT, INR, AND PT% USING THE SAME SYSTEM AND REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER. THESE FINAL PT, INR, AND PT% RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). A DISCORDANT, FALSELY LOW PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT, AS WELL AS A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME PERCENT (PT%) RESULT WERE THEN OBTAINED WHEN RUNNING THE SAME PATIENT SAMPLE IN AN ALTERNATE TUBE ON THE SYSMEX CA-660 SYSTEM USING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10442770 ↗
• 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 ↗

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