Thromborel® S 10446442Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842768011306), received between Aug 24, 2020 and Aug 24, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗