Dade® Innovin® 10445704Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00842768003783), received between Jun 30, 2017 and Mar 3, 2023 — classified as 32 malfunctions.

The most frequently reported specific device problem is “High Test Results” (17 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  SYSMEX REPORTED TO SIEMENS THAT A CUSTOMER SUSTAINED AN INJURY TO THE HAND WHILE OPENING A DADE INNOVIN VIAL, WHICH WAS DIRECTLY EXTRACTED FROM THE PACKAGING BOX. THE CUSTOMER DEMONSTRATED THE NECK OF THE VIAL WAS BROKEN. THE CUSTOMER WAS THEN GIVEN A MINI X-RAY TO ENSURE THAT THERE WERE NO GLASS FRAGMENTS IN THE WOUND. THE WOUND WAS CLEANED AND DISINFECTED AND PROTECTED WITH STERI-STRIPS. NO FURTHER TREATMENT WAS NECESSARY. THE CUSTOMER RETURNED TO WORK THE SAME DAY. THE CUSTOMER WAS WEARING A LAB COAT AND LATEX GLOVES AT THE TIME OF THE INCIDENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.

  Patient problems: Laceration(s)

  MAUDE report 16482208 ↗
• MalfunctionJun 16, 2021Incorrect, 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, AND A DISCORDANT, FALSELY LOW PROTHROMBIN TIME PERCENT (PT%) RESULT WERE OBTAINED ON A SYSMEX CS-5100 SYSTEM USING DADE INNOVIN REAGENT. THE RESULTS DID NOT MATCH WITH RESULTS OBTAINED ON A NON-SIEMENS SYSTEM USING A NON-SIEMENS REAGENT THE DAY PRIOR. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND WAS RUN FOR PT, INR, AND PT% ON AN ALTERNATE SYSMEX CS-5100 SYSTEM USING DADE INNOVIN REAGENT, AS WELL AS ON A NON-SIEMENS SYSTEM USING A NON-SIEMENS REAGENT AT AN ALTERNATE LABORATORY. THE PT AND INR RECOVERED FALSELY HIGH AND THE PT% RECOVERED FALSELY LOW, COMPARED TO THE RESULTS OBTAINED ON THE NON-SIEMENS SYSTEM. THREE DAYS LATER, AFTER THE PATIENT HAD STARTED VITAMIN K ADMINISTRATION AND HAD SWITCHED THEIR ANTICOAGULANT TO LOVENOX, A NEW SAMPLE WAS DRAWN AND WAS RUN FOR PT% ON A SYSMEX CS-5100 SYSEM USING DADE INNOVIN REAGENT AS WELL AS ON A NON-SIEMENS SYSTEM USING A NON-SIEMENS REAGENT. THE PT% RECOVERED FALSELY LOW COMPARED TO THE RESULTS OBTAINED ON THE NON-SIEMENS SYSTEM. THERE ARE NO KNOWN REPORTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009052 ↗
• MalfunctionJun 16, 2021Incorrect, 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, AND A DISCORDANT, FALSELY LOW PROTHROMBIN TIME PERCENT (PT%) RESULT WERE OBTAINED ON A SYSMEX CS-5100 SYSTEM USING DADE INNOVIN REAGENT. THE RESULTS DID NOT MATCH WITH RESULTS OBTAINED ON A NON-SIEMENS SYSTEM USING A NON-SIEMENS REAGENT THE DAY PRIOR. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND WAS RUN FOR PT, INR, AND PT% ON AN ALTERNATE SYSMEX CS-5100 SYSTEM USING DADE INNOVIN REAGENT, AS WELL AS ON A NON-SIEMENS SYSTEM USING A NON-SIEMENS REAGENT AT AN ALTERNATE LABORATORY. THE PT AND INR RECOVERED FALSELY HIGH AND THE PT% RECOVERED FALSELY LOW, COMPARED TO THE RESULTS OBTAINED ON THE NON-SIEMENS SYSTEM. THREE DAYS LATER, AFTER THE PATIENT HAD STARTED VITAMIN K ADMINISTRATION AND HAD SWITCHED THEIR ANTICOAGULANT TO LOVENOX, A NEW SAMPLE WAS DRAWN AND WAS RUN FOR PT% ON A SYSMEX CS-5100 SYSEM USING DADE INNOVIN REAGENT AS WELL AS ON A NON-SIEMENS SYSTEM USING A NON-SIEMENS REAGENT. THE PT% RECOVERED FALSELY LOW COMPARED TO THE RESULTS OBTAINED ON THE NON-SIEMENS SYSTEM. THERE ARE NO KNOWN REPORTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009020 ↗
• MalfunctionFeb 1, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-5100 SYSTEM USING DADE INNOVIN REAGENT AND WAS FLAGGED WITH ERROR MESSAGES. THE SAMPLE WAS ALSO RUN FOR PROTHROMBIN TIME PERCENT (PT%) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) AT THE SAME TIME, BUT NO NUMERIC RESULTS WERE GENERATED. THE SAMPLE WAS THEN REPEATED FOR INR, RESULTING FALSELY ELEVATED. THE SAME SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% WITH THE SAME SYSTEM AND REAGENT. THE PT AND INR RECOVERED FALSELY ELEVATED AND THE PT% RECOVERED FALSELY LOW. THE SAME SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ON THE SAME SYSMEX CS-5100 SYSTEM BUT USING THROMBOREL S REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER. THE SAME SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ON AN ALTERNATE SYSMEX CS-5100 SYSTEM USING DADE INNOVIN REAGENT. THE PT AND INR RECOVERED LOWER THAN THE INITIAL DISCORDANT RESULTS AND THE PT% RECOVERED HIGHER THAN THE INITIAL DISCORDANT RESULT. THE INR RESULT OBTAINED ON THE ALTERNATE SYSMEX CS-5100 SYSTEM USING DADE INNOVIN REAGENT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11263106 ↗
• MalfunctionAug 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING DADE INNOVIN REAGENT. PRIOR TO OBTAINING THE DISCORDANT RESULTS, THE SAMPLE WAS RUN FOR PT ON THE SAME SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) WITH DADE INNOVIN REAGENT, GENERATING AN ELEVATED, FLAGGED RESULT. AFTER THE INITIAL DISCORDANT RESULTS WERE OBTAINED, THE SAME SAMPLE WAS REPEATED FOR PT, INR, AND PROTHROMBIN TIME PERCENT (PT%) ON AN ALTERNATE SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING DADE INNOVIN REAGENT. THE PT AND INR RECOVERED LOWER, BUT WERE STILL CONSIDERED FALSELY ELEVATED. THE PT% RECOVERED FALSELY LOW. THE SAME SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ON THE SAME SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING THROMBOREL S REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER. THE SAME SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ON THE SAME SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING DADE INNOVIN REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER. THE SAM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10437291 ↗
• MalfunctionJun 12, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING DADE INNOVIN REAGENT. THE SAMPLE HAD PREVIOUSLY BEEN RUN FOR PT AND INR ON AN ALTERNATE SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING DADE INNOVIN REAGENT WHICH GENERATED A "NO COAGULATION" ERROR AND NO NUMERIC RESULTS. THE DISCORDANT, FALSELY ELEVATED PT AND INR RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE PATIENT WAS SENT TO AN ALTERNATE HOSPITAL TO BE REDRAWN AND RETESTED FOR INR. THE NEW SAMPLE WAS RUN FOR INR ON A NON-SIEMENS ANALYZER, RESULTING LOWER. THIS RESULT WAS CONSIDERED CORRECT. THE ORIGINAL SAMPLE WAS SENT TO THE ALTERNATE HOSPITAL AND WAS RUN FOR INR ON A NON-SIEMENS ANALYZER, RESULTING LOWER. THIS RESULT WAS ALSO CONSIDERED CORRECT. THE NEXT DAY, THE ORIGINAL SAMPLE WAS RETESTED FOR PT AND INR AT THE CUSTOMER'S SITE. THE PT AND INR BOTH RECOVERED FALSELY ELEVATED. THESE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY E

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10148367 ↗
• MalfunctionJun 12, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING DADE INNOVIN REAGENT. THE SAMPLE HAD PREVIOUSLY BEEN RUN FOR PT AND INR ON AN ALTERNATE SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING DADE INNOVIN REAGENT WHICH GENERATED A "NO COAGULATION" ERROR AND NO NUMERIC RESULTS. THE DISCORDANT, FALSELY ELEVATED PT AND INR RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE PATIENT WAS SENT TO AN ALTERNATE HOSPITAL TO BE REDRAWN AND RETESTED FOR INR. THE NEW SAMPLE WAS RUN FOR INR ON A NON-SIEMENS ANALYZER, RESULTING LOWER. THIS RESULT WAS CONSIDERED CORRECT. THE ORIGINAL SAMPLE WAS SENT TO THE ALTERNATE HOSPITAL AND WAS RUN FOR INR ON A NON-SIEMENS ANALYZER, RESULTING LOWER. THIS RESULT WAS ALSO CONSIDERED CORRECT. THE NEXT DAY, THE ORIGINAL SAMPLE WAS RETESTED FOR PT AND INR AT THE CUSTOMER'S SITE. THE PT AND INR BOTH RECOVERED FALSELY ELEVATED. THESE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY E

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10148365 ↗
• MalfunctionJun 11, 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 DADE INNOVIN REAGENT. THE SAMPLE WAS REPEATED FOR PT, INR, AND PT% ON AN ALTERNATE SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING DADE INNOVIN REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER. THE SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% AGAIN ON SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING THROMBOREL S REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER COMPARED TO THE INITIAL DISCORDANT RESULTS. THE SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ONCE MORE ON SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING DADE INNOVIN REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER COMPARED TO THE INITIAL DISCORDANT RESULTS. THE LAST INR RESULT OBTAINED WITH DADE INNOVIN REAGENT 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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10143937 ↗
• MalfunctionMay 12, 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 DADE INNOVIN REAGENT. PRIOR TO OBTAINING THE DISCORDANT RESULTS, THE SAMPLE WAS RUN FOR INR, BUT THE SYSTEM DID NOT YIELD NUMERIC RESULTS AND GENERATED A NO COAGULATION ERROR. AFTER THE DISCORDANT RESULTS WERE OBTAINED, THE SAMPLE WAS REPEATED FOR PT, INR, AND PT% ON THE SAME SYSTEM USING THROMBOREL S REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER. THE SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ON AN ALTERNATE SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING DADE INNOVIN REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% REMAINED THE SAME. THE SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ON THE SAME ALTERNATE SYSTEM USING THROMBOREL S REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER COMPARED TO THE PREVIOUS RESULTS OBTAINED WITH THROMBOREL S REAGENT. THE LAST INR RESULT OBTAINED WITH DADE INNOVIN REAGENT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10047019 ↗
• MalfunctionMay 8, 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 DADE INNOVIN REAGENT. THE SAMPLE WAS REPEATED FOR PT (EXTENDED) AND INR (EXTENDED) ON THE SAME SYSTEM WITH THE SAME REAGENT, BOTH OF WHICH RECOVERED LOWER. THE SAMPLE WAS THEN REPEATED ON AN ALTERNATE SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) FOR PT, INR, AND PT% USING DADE INNOVIN REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER. THE SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ON THE SAME ALTERNATE SYSTEM USING THROMBOREL S REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER. THE SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ON THE SAME ALTERNATE SYSTEM USING DADE INNOVIN REAGENT. THE PT AND INR RECOVERED HIGHER AND THE PT% RECOVERED LOWER. THE SAMPLE WAS THEN REPEATED ONE FINAL TIME FOR PT, INR, AND PT% ON THE SAME ALTERNATE SYSTEM USING DADE INNOVIN REAGENT. THE PT AND INR RECOVERED LOWER AND THE PT% RECOVERED HIGHER. THIS LAST INR RESULT WAS REPORTED, AS TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10039003 ↗
• MalfunctionApr 8, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) (EXTENDED) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING DADE INNOVIN REAGENT. THE SAMPLE WAS ALSO RUN AT SAME TIME FOR PROTHROMBIN TIME (PT), PROTHROMBIN TIME PERCENT (PT%), AND INR, BUT THE SYSTEM DID NOT YIELD NUMERIC RESULTS. THE SAME SAMPLE WAS REPEATED FOR PT, PT%, AND INR ON AN ALTERNATE SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) USING THROMBOREL S REAGENT, RESULTING LOWER. THE SAME SAMPLE WAS THEN REPEATED TWICE FOR PT, PT%, AND INR ON THE FIRST SYSMEX CS-5100 SYSTEM (SERIAL NUMBER: (B)(4)) WITH DADE INNOVIN REAGENT, ALL RESULTING LOWER. THE SECOND REPEAT INR 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) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9934906 ↗
• 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 9316680 ↗
• MalfunctionNov 12, 2019High Test Results; High Test Results

  FOUR DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS, FOUR DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS, AND TWO DISCORDANT, FALSELY LOW PROTHROMBIN TIME PERCENT (PT%) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-5100 SYSTEM USING DADE INNOVIN REAGENT. AFTER OBTAINING THESE DISCORDANT RESULTS, THE SAME SAMPLE WAS REPEATED FOR PT, INR, AND PT% ON THE SAME SYSTEM WITH THROMBOREL S REAGENT. THE PT AND INR RESULTED LOWER AND THE PT% RESULTED HIGHER. A NEW SAMPLE FROM THE SAME PATIENT WAS RUN TWICE FOR PT, INR, AND PT% ON AN ALTERNATE SYSMEX CS-5100 SYSTEM USING DADE INNOVIN REAGENT. THE PT AND INR RESULTED LOWER THAN THE RESULTS PREVIOUSLY OBTAINED USING DADE INNOVIN REAGENT AND THE PT% RESULTED HIGHER THAN THE RESULTS PREVIOUSLY OBTAINED USING DADE INNOVIN REAGENT. THE SAMPLE WAS THEN REPEATED AGAIN FOR PT, INR, AND PT% ON THE SAME ALTERNATE SYSMEX CS-5100 USING THROMBOREL S REAGENT. THE PT AND INR RESULTED LOWER THAN THE RESULTS PREVIOUSLY OBTAINED USING DADE INNOVIN REAGENT AND THE PT% RESULTED HIGHER THAN THE RESULTS PREVIOUSLY OBTAINED USING DADE INNOVIN REAGENT. THE LAST INR RESULT OBTAINED WITH DADE INNOVIN REA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9309883 ↗
• MalfunctionOct 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 DADE INNOVIN REAGENT. THE SAME SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ON THE SAME SYSTEM WITH DADE INNOVIN REAGENT. THE PT AND INR RESULTED LOWER AND THE PT% RESULTED HIGHER. USING THROMBOREL S REAGENT, THE SAME SAMPLE WAS TESTED FOR PT, INR, AND PT% ON THE SAME SYSTEM. THE PT AND INR RESULTED LOWER AND THE PT% RESULTED HIGHER. THE SAME SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ON AN ALTERNATE SYSMEX CS-5100 SYSTEM USING DADE INNOVIN REAGENT. THE PT AND INR RESULTED LOWER AND THE PT% RESULTED HIGHER THAN THE INITIAL DISCORDANT RESULTS. USING THROMBOREL S REAGENT, THE SAME SAMPLE WAS THEN REPEATED FOR PT, INR, AND PT% ON THE SAME ALTERNATE SYSTEM. THE PT AND INR RESULTED LOWER AND THE PT% RESULTED HIGHER. THE FOLLOWING DAY, A NEW SAMPLE FROM THE SAME PATIENT WAS TESTED FOR PT, INR AND PT% USING DADE INNOVIN REAGENT ON THE SAME TWO SYSMEX CS-5100 SYSTEMS THAT WERE USED THE PREVIOUS DAY. TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9239823 ↗
• MalfunctionSep 24, 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 DADE INNOVIN REAGENT. THE SAME SAMPLE WAS REPEATED FOR PT AND INR ON THE SAME SYSTEM USING DADE INNOVIN REAGENT, BOTH RESULTING LOWER. THE SAME SAMPLE WAS THEN REPEATED A THIRD TIME FOR PT, INR, AND PT% ON THE SAME SYSTEM WITH DADE INNOVIN REAGENT. THE PT AND INR RESULTED LOWER AND THE PT% RESULTED HIGHER. USING THROMBOREL S REAGENT, THE SAME SAMPLE WAS TESTED FOR PT, INR, AND PT% ON THE SAME SYSTEM. THE PT AND INR RESULTED LOWER AND THE PT% RESULTED HIGHER. THE SAME SAMPLE WAS THEN REPEATED AGAIN FOR PT, INR, AND PT% ON THE SAME SYSTEM WITH DADE INNOVIN REAGENT. THE PT AND INR RESULTED HIGHER AND THE PT% RESULTED LOWER. THE SAME SAMPLE WAS THEN TESTED FOR PT, INR, AND PT% ON AN ALTERNATE SYSMEX CS-5100 SYSTEM USING DADE INNOVIN REAGENT. THE PT AND INR RESULTED LOWER AND THE PT% RESULTED HIGHER. USING THROMBOREL S REAGENT, THE SAME SAMPLE WAS THEN TESTED FOR PT, INR, AND PT% ON THE SAME ALTERNATE S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9111269 ↗
• MalfunctionSep 18, 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 DADE INNOVIN REAGENT. THE SAME SAMPLE WAS REPEATED FOR PT AND INR ON THE SAME SYSTEM USING DADE INNOVIN REAGENT, BOTH RESULTING LOWER. THE SAME SAMPLE WAS THEN REPEATED AGAIN FOR PT, INR, AND PT% ON THE SAME SYSTEM WITH DADE INNOVIN REAGENT. THE PT AND INR RESULTED LOWER AND THE PT% RESULTED HIGHER. THE SAME SAMPLE WAS REPEATED AGAIN FOR PT, INR, AND PT% ON THE SAME SYSTEM USING THROMBOREL S REAGENT. THE PT AND INR RESULTED LOWER AND THE PT% RESULTED HIGHER. THE SAME SAMPLE WAS THEN REPEATED AGAIN FOR PT, INR, AND PT% ON THE SAME SYSTEM WITH DADE INNOVIN REAGENT, ALL RESULTING LOWER. THE SAME SAMPLE WAS REPEATED AGAIN FOR PT, INR, AND PT% ON THE SAME SYSTEM USING THROMBOREL S REAGENT. THE INR RESULTED LOWER AND THE PT AND PT% RESULTED HIGHER. THE LAST INR RESULT OBTAINED WITH DADE INNOVIN REAGENT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9084197 ↗
• MalfunctionJun 13, 2019High Test Results; Low Test Results; High Test Results; Low Test Results

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT, A DISCORDANT, FALSELY LOW PROTHROMBIN TIME PERCENT (PT%) RESULT, AND A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-5100 SYSTEM USING DADE INNOVIN REAGENT (LOT#: 549716). THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED BY THE PHYSICIAN(S). THE SAME SAMPLE WAS SENT TO A DIFFERENT LAB AND WAS RUN FOR PT% AND INR ON A NON-SIEMENS INSTRUMENT WITH UNKNOWN REAGENT, RESULTING IN HIGHER PT% AND LOWER INR RESULTS. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). DUE TO THE DISCORDANT FALSELY ELEVATED PT AND PT INR RESULTS AND THE DISCORDANT FALSELY LOW PT% RESULTS, VITAMIN K REVERSAL THERAPY WAS STARTED ON THE PATIENT; HOWEVER, THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THE VITAMIN K REVERSAL THERAPY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8696771 ↗
• MalfunctionJun 13, 2019High Test Results; Low Test Results; High Test Results; Low Test Results

  TWO DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS, TWO DISCORDANT, FALSELY LOW PROTHROMBIN TIME PERCENT (PT%) RESULTS, AND TWO DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON TWO SAMPLES FROM THE SAME PATIENT ON A SYSMEX CS-5100 SYSTEM USING DADE INNOVIN REAGENT (LOT#: 549716). THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED BY THE PHYSICIAN(S). THE FOLLOWING DAY, A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS RUN FOR PT% AND INR ON A NON-SIEMENS INSTRUMENT WITH UNKNOWN REAGENT, RESULTING IN HIGHER PT% AND LOWER INR RESULTS. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). DUE TO THE DISCORDANT FALSELY ELEVATED PT AND PT INR RESULTS AND THE DISCORDANT FALSELY LOW PT% RESULTS, VITAMIN K REVERSAL THERAPY WAS STARTED ON THE PATIENT; HOWEVER, THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THE VITAMIN K REVERSAL THERAPY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8696693 ↗
• MalfunctionJun 5, 2019High Test Results; High Test Results

  AN INITIAL, DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT EXPRESSED AS PT SECONDS WAS OBTAINED ON A PATIENT SAMPLE USING THE DADE INNOVIN REAGENT, ON A SYSMEX CS-5100 SYSTEM. ADDITIONALLY, NON-NUMERICAL PT % AND PT INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON THE SAMPLE WITH FLAGS BY THE INSTRUMENT. THE SAMPLE WAS REPEATED THREE TIMES USING THE SAME DADE INNOVIN REAGENT AND A THROMBOREL S REAGENT ON AN ALTERNATE SYSMEX CS-5100 SYSTEM, RESULTING LOWER FOR PT SECONDS AND PT INR. THE FINAL THROMBOREL S PT INR RESULT OF 2.92 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 8671730 ↗
• MalfunctionMar 22, 2019High Test Results; Low Test Results; High Test Results; Low Test Results

  DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS EXPRESSED AS PT SECONDS AND PT INTERNATIONAL NORMALIZED RATIO (INR) WERE OBTAINED ON A PATIENT SAMPLE, USING THE DADE INNOVIN REAGENT, ON A SYSMEX CS-5100 SYSTEM. ADDITIONALLY, A NON-NUMERICAL PT % RESULT WAS OBTAINED ON THE SAMPLE. THE SAMPLE WAS REPEATED THREE TIMES USING THE SAME REAGENT AND AN ALTERNATE THROMBOREL S REAGENT, RESULTING LOWER FOR PT SECONDS AND PT INR. NONE OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). ON THE NEXT DAY, A DIFFERENT SAMPLE FROM THE PATIENT WAS RUN ON AN ALTERNATE SYSMEX CS-5100 SYSTEM, RESULTING LOWER FOR PT SECONDS AND PT INR. THE PT INR RESULT OF 1.25 WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE IS NO REPORT OF ADVERSE EVENT NOR TREATMENT PROVIDED DUE TO THE DISCORDANT PT, PT INR, PT% RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8444672 ↗
• MalfunctionJan 10, 2019Incorrect, 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 A PATIENT SAMPLE, USING THE DADE INNOVIN REAGENT, ON A SYSMEX CS-5100 SYSTEM. ADDITIONALLY, A DISCORDANT, FALSELY LOW PT % RESULT WAS OBTAINED ON THE SAME SAMPLE, USING THE SAME REAGENT. THE SAMPLE WAS REPEATED THREE MORE TIMES ON THE SAME SYSTEM; TWICE USING THE SAME DADE INNOVIN REAGENT LOT AND ONCE USING AN ALTERNATE THROMBOREL S REAGENT, AND LOWER PT AND PT INR RESULTS AND A HIGHER PT % RESULTS WERE OBTAINED. NONE OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED, USING THE DADE INNOVIN REAGENT AND THE THROMBOREL S REAGENT, ON AN ALTERNATE SYSMEX CS-5100 SYSTEM, AND COMPARED TO THE DISCORDANT RESULTS, LOWER PT AND PT INR RESULTS AND HIGHER PT % RESULTS WERE OBTAINED. THE PT INR RESULT OF 0.96 INR 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 AND THE DISCORDANT, FALSELY LOW PT % RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8233501 ↗
• MalfunctionDec 28, 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 A PATIENT SAMPLE USING THE DADE INNOVIN REAGENT ON TWO SYSMEX CS-5100 SYSTEMS. ADDITIONALLY, DISCORDANT, FALSELY LOW PT % RESULTS WERE OBTAINED ON THE SAME SAMPLE, USING THE SAME REAGENT. NONE OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED, USING THE THROMBOREL S REAGENT, RESULTING LOWER FOR PT AND PT INR, AND HIGHER FOR PT %. THE SAMPLE WAS REPEATED USING THE SAME DADE INNOVIN REAGENT LOT AND THE SAME THROMBOREL S REAGENT LOT THREE TIMES. THE PT INR RESULT OF 2.65 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 AND THE DISCORDANT, FALSELY LOW PT % RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8202382 ↗
• MalfunctionJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 THE SYSMEX CS-5100 SYSTEM. ADDITIONALLY, DISCORDANT, FALSELY LOW PT % RESULTS WERE OBTAINED ON THE SAME SAMPLE, USING THE SAME REAGENT. THE SAMPLE WAS RERUN IN EXTENDED TIME, USING THE SAME REAGENT, RESULTING IN ANOTHER DISCORDANT PT INR RESULT. NONE OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN USING THE SAME REAGENT AND AN ALTERNATE THROMBOREL S REAGENT, IN DUPLICATE, RESULTING IN LOWER PT AND PT INR RESULTS AND HIGHER PT % RESULTS. THE FINAL PT INR RESULT, OBTAINED USING THE DADE INNOVIN REAGENT, 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 AND DISCORDANT, FALSELY LOW PT % RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7628952 ↗
• MalfunctionMay 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FLAGGED, NON-NUMERICAL PROTHROMBIN TIME (PT), PT % AND PT INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON A PATIENT SAMPLE, USING THE DADE INNOVIN REAGENT, ON TWO SYSMEX CS-5100 SYSTEMS. THE SAMPLE WAS RERUN IN EXTENDED TIME USING THE DADE INNOVIN REAGENT THREE TIMES, RESULTING IN DISCORDANT, FALSELY ELEVATED PT INR RESULTS. THE SAME SAMPLE WAS RERUN ON ONE OF THE SYSMEX CS-5100 SYSTEMS, USING THE THROMBOREL S REAGENT, RESULTING IN A LOWER PT INR RESULT. NONE OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). ON THE NEXT DAY, A NEW SAMPLE FROM THE PATIENT WAS RUN ON ONE OF THE SYSMEX CS-5100 SYSTEMS, USING THE DADE INNOVIN REAGENT, AND ON THE OTHER SYSMEX CS-5100 SYSTEM, USING THE THROMBOREL S REAGENT. PT INR RESULTS LOWER THAN THE DISCORDANT, FALSELY ELEVATED PT INR RESULTS, OBTAINED USING THE DADE INNOVIN REAGENT, WERE OBTAINED ON THE NEW SAMPLE. THE FINAL PT INR RESULT OF 4.94 INR, OBTAINED USING THE DADE INNOVIN REAGENT, WAS REPORTED TO THE PHYSICIAN(S) AS IT CORRESPONDED TO THE PATIENT'S MEDICAL CONDITIONS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PT INR RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7526944 ↗
• MalfunctionFeb 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FLAGGED PROTHROMBIN TIME (PT) INTERNATIONAL NORMALIZED RATIO (INR) RESULT, A DISCORDANT FALSELY LOW PT % RESULT, AND A DISCORDANT, FALSELY ELEVATED PT RESULT WERE OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CS-5100 SYSTEM, USING THE DADE INNOVIN REAGENT. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S) AND THE SAMPLE WAS RERUN USING EXTENDED TIME, RESULTING IN DISCORDANT, FALSELY ELEVATED PT INR AND PT RESULTS. THE SAME SAMPLE WAS RERUN ON THE SAME SYSTEM, USING THE SAME REAGENT AND AN ALTERNATE REAGENT (THROMBOREL S), RESULTING IN LOWER PT INR RESULTS, HIGHER PT% RESULT AND LOWER PT RESULTS. THE SAME SAMPLE WAS RERUN ON THE SAME SYSTEM USING BOTH REAGENTS. THE FINAL PT INR RESULT OBTAINED, USING THE DADE INNOVIN REAGENT, 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 INR RESULTS, DISCORDANT, FALSELY LOW PT % RESULTS, AND DISCORDANT, FALSELY ELEVATED PT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7249157 ↗