Dade® Innovin® 10445706Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00842768003806), received between Jul 18, 2017 and Mar 20, 2026 — classified as 35 malfunctions.

The most frequently reported specific device problem is “High Test Results” (12 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026False Positive Result

  THE CUSTOMER REPORTED FALSELY ELEVATED PT (PROTHROMBIN TIME) INR (INTERNATIONAL NORMALIZED RATIO) AND SEC (SECONDS) RESULTS OBTAINED ON A PATIENT SAMPLE MEASURED WITH DADE INNOVIN ON THE CA-660 INSTRUMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULT. 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 THIS DISCORDANT FALSELY ELEVATED PT INR AND SEC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646948 ↗
• MalfunctionSep 3, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT INCREASED PT (PROTHROMBIN TIME) INR (INTERNATIONAL NORMALIZED RATIO) RESULTS OBTAINED ON FIVE PATIENT SAMPLES MEASURED WITH DADE INNOVIN ON THE CN-3000 INSTRUMENT COMPARED TO REPEAT TESTING. IT IS UNKNOWN WHETHER PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN. PATIENT SAMPLE TESTING WAS REPEATED AS QUALITY CONTROL RESULTS WERE OUT OF RANGE AND INVALIDATED THE INITIAL RUN. 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 22949724 ↗
• MalfunctionJun 10, 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 A PATIENT SAMPLE MEASURED WITH DADE INNOVIN ON THE CS-2500 INSTRUMENT. 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 22175775 ↗
• MalfunctionMay 26, 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 DADE INNOVIN ON THE CS-5100 INSTRUMENT COMPARED TO THE ALTERNATE METHOD. 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 22083269 ↗
• MalfunctionDec 2, 2024Use of Device Problem; High Test Results; Use of Device Problem; High Test Results

  THE CUSTOMER OBTAINED NON-NUMERIC, FLAGGED, INR PATIENT RESULTS AND FALSELY ELEVATED PT RESULTS MEASURED WITH DADE INNOVIN REAGENT ON A SYSMEX CS-2500 INSTRUMENT. THE CUSTOMER MANUALLY CALCULATED AN INR RESULT OF 10.0 SECONDS AND THIS RESULT WAS REPORTED TO, AND QUESTIONED BY, THE PHYSICIAN(S). THE SAMPLE WAS REPEATED AT ANOTHER LABORATORY AND AN INR RESULT OF 2.3 SECONDS WAS OBTAINED AND REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). A SECOND SAMPLE FROM THE PATIENT WAS ALSO TESTED ON THE INITIAL INSTRUMENT AND RESULTS OF PT 22.1 SECONDS, INR 2.02 SECONDS WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818238 ↗
• MalfunctionJan 6, 2022Low 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 USING DADE INNOVIN REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT SUBSEQUENTLY HAD A BLEEDING EPISODE AND WAS GIVEN VITAMIN K AND PROTHROMBINEX. THERE WAS A DELAY IN ADMINISTERING VITAMIN K AND PROTHROMBINEX DUE TO THE LOW RESULT. THE FOLLOWING DAY, THE SAME SAMPLE WAS RERUN FOR INR, RECOVERING HIGHER. THE PATIENT WAS THEN REDRAWN AND THE REDRAWN SAMPLE WAS RUN TWICE FOR INR, RECOVERING HIGHER THAN THE INITIAL DISCORDANT RESULT. THE HIGHER INR RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) RESULT, THE DELAY IN ADMINISTERING VITAMIN K AND PROTHROMBINEX, OR DUE TO THE BLEEDING. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVEN'T BEEN VERIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13178845 ↗
• MalfunctionDec 16, 2021High 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 CA-660 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS GIVEN FRESH FROZEN PLASMA DURING BRAIN SURGERY BASED ON THE DISCORDANT, FALSELY ELEVATED INR RESULT. THE SAMPLE WAS REPEATED FOR INR, RECOVERING LOWER. THE LOWER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ADMINISTRATION OF FRESH FROZEN PLASMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018346 ↗
• MalfunctionAug 5, 2020High 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 NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME SYSTEM USING THE SAME REAGENT, RESULTING LOWER. THIS RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THE FOLLOWING DAY, ANOTHER DISCORDANT, FALSELY ELEVATED PT RESULT WAS OBTAINED ON ANOTHER SAMPLE FROM THE SAME PATIENT ON THE SAME SYSMEX CA-660 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS REDRAWN AND THE REDRAWN SAMPLE WAS RUN FOR PT ON THE SAME SYSMEX CA-660 SYSTEM USING DADE INNOVIN REAGENT, RESULTING LOWER. 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 (PT) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10367914 ↗
• MalfunctionAug 5, 2020High 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 NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME SYSTEM USING THE SAME REAGENT, RESULTING LOWER. THIS RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THE FOLLOWING DAY, ANOTHER DISCORDANT, FALSELY ELEVATED PT RESULT WAS OBTAINED ON ANOTHER SAMPLE FROM THE SAME PATIENT ON THE SAME SYSMEX CA-660 SYSTEM USING DADE INNOVIN REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS REDRAWN AND THE REDRAWN SAMPLE WAS RUN FOR PT ON THE SAME SYSMEX CA-660 SYSTEM USING DADE INNOVIN REAGENT, RESULTING LOWER. 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 (PT) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10367912 ↗
• MalfunctionOct 25, 2018High Test Results; High Test Results

  FLAGGED NON-NUMERICAL PROTHROMBIN TIME (PT) INTERNATIONAL NORMALIZED RATIO (INR) AND PT % RESULTS AND A DISCORDANT, FALSELY ELEVATED PT RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-2100I SYSTEM, USING THE DADE INNOVIN REAGENT. THE SAMPLE WAS REPEATED ON THE SAME SYSTEM, USING THE SAME REAGENT LOT (IN EXTENDED TIME), AND DISCORDANT, FALSELY ELEVATED PT INR AND PT RESULTS WERE OBTAINED ON THE PATIENT SAMPLE. THE SAMPLE WAS REPEATED IN MICRO-MODE ON THE SAME SYSTEM, USING THE SAME REAGENT LOT, RESULTING LOWER FOR PT INR AND PT. NONE OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PATIENT'S BLOOD WAS RE-DRAWN AND THE NEW SAMPLE WAS REPEATED ON THE SAME SYSTEM AND REAGENT LOT; THE RESULTS OBTAINED ON THE NEW SAMPLE WERE LOWER THAN THE DISCORDANT RESULTS AND THE PT 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 DISCORDANT, FALSELY ELEVATED PT INR AND PT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005667 ↗
• MalfunctionOct 23, 2018High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) AND PT INTERNATIONAL NORMALIZED (INR) RESULTS WERE OBTAINED ON THE SYSMEX CS-2100I SYSTEM, USING THE DADE INNOVIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE PATIENT WAS SENT TO AN ALTERNATE LABORATORY, WHERE THE PATIENT WAS REDRAWN AND THE NEW SAMPLE WAS RUN ON A NON-SIEMENS SYSTEM RESULTING, LOWER. THE RESULTS OBTAINED ON THE NON-SIEMENS SYSTEM WERE 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 7996692 ↗
• MalfunctionSep 24, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A NON-NUMERICAL PROTHROMBIN TIME (PT) RESULT OF "NO COAGULATION" WAS OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CS-2100I SYSTEM USING DADE INNOVIN REAGENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS RE-DRAWN AND THE NEW SAMPLE WAS RUN ON THE SAME SYSTEM AND USING THE SAME REAGENT. THE RESULTS OBTAINED ON THE REDRAWN SAMPLE WAS CONSIDERED TO BE CORRECT AND THE PT INTERNATIONAL NORMALIZED RATIO (INR) WAS REPORTED TO THE PHYSICIAN(S). THE INITIAL SAMPLE WAS REPEATED ON THE SAME SYSTEM AND USING THE SAME REAGENT, RESULTING IN A LOWER PT AND PT INR RESULT AND A HIGHER PT % RESULTS. THE INITIAL SAMPLE WAS ALSO REPEATED USING THE SAME SYSTEM AND SAME REAGENT IN EXTENDED TIME, RESULTING IN A FLAGGED NO COAGULATION RESULT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PT INR RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7903839 ↗
• MalfunctionJul 6, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MULTIPLE DISCORDANT PROTHROMBIN TIME (PT) PATIENT SAMPLE RESULTS WERE GENERATED ON A SYSMEX CA-620 SYSTEM (SERIAL NUMBER (B)(4)) AND REPORTED TO PHYSICIANS FOR USING DADE INNOVIN LOT 539388 WHEN QUALITY CONTROL (QC) FOR PT WAS OUT OF RANGE. SOME PATIENT SAMPLES WERE RUN FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) USING DADE ACTIN FSL ACTIVATED PTT REAGENT LOT 556912. ON THE FOLLOWING DAY ((B)(6) 2018), ALL PATIENT SAMPLES WERE RETESTED AT AN ALTERNATE LABORATORY ON A SYSMEX CS-2500 SYSTEM, USING DADE INNOVIN LOT 549704 AND DADE ACTIN FSL ACTIVATED PTT REAGENT LOT 556904. NO CORRECTED REPORTS WERE ISSUED TO PHYSICIANS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PT/ INR PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7666404 ↗
• MalfunctionMar 2, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  DISCORDANT PROTHROMBIN TIME (PT) PATIENT RESULTS WERE GENERATED ON SYSMEX CA-560 ANALYZER ON THREE (3) SEPARATE PATIENTS' SAMPLES. QUALITY CONTROL WAS WITHIN RANGE. FOR PATIENTS1 AND 2, DISCORDANT HIGH PT PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN. FOR PATIENT 1, NO MEDICATIONS WERE ADMINSTERED. FOR PATIENT 2, VITAMIN K THERAPY WAS ADMINISTERED. CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN AFTER THE SAME SAMPLES FROM PATIENTS 1 AND 2 WERE RETESTED ON THE SAME SYSTEM AND LOWER PT PATIENT RESULTS WERE GENERATED. FOR PATIENT 3, AN INITIAL PT RESULT OF "NO COAGULATION" WAS GENERATED WHICH WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS RETESTED TWICE ON THE SAME SYSTEM AND PT RESULTS OF 29.8 SECONDS AND 30.4 SECONDS WERE GENERATED. THE PT RESULT OF 29.8 SECONDS WAS REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PT PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7310460 ↗
• MalfunctionMar 2, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A DISCORDANT, LOW PROTHROMBIN TIME (PT) PATIENT RESULT OF 13.1 SECONDS WAS GENERATED ON SYSMEX CA-560 ANALYZER. THE PT RESULT WAS NOT REPORTED TO THE PHYSICIAN. QUALITY CONTROL WAS WITHIN RANGE. THE SAME SAMPLE WAS REPEATED TWICE ON THE SAME SYSTEM AND PT RESULTS OF 32.0 SECONDS AND 31.9 SECONDS WERE GENERATED. THE PT RESULT OF 32.0 SECONDS WAS REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PT PATIENT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7310455 ↗
• MalfunctionJan 30, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  ONE PATIENT SAMPLE (SAMPLE 1) WAS RUN ON THE SYSMEX CA-660 ANALYZER WHICH GENERATED A PROTHROMBIN TIME (PT)/ INTERNATIONAL NORMALIZED RATIO (INR) RESULT OF "NO COAGULATION." THIS RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. ALL QUALITY CONTROL (QC) WAS IN RANGE PRIOR TO TESTING. THE SAME SAMPLE WAS RUN ON THE SAME SYSTEM (SYSMEX CA-660 ANALYZER) TWO (2) MORE TIMES GENERATING THE SAME PT/INR RESULT ""NO COAGULATION." THE SAME SAMPLE WAS THEN RUN ON AN ABBOTT ISTAT POINT OF CARE ANALYZER (NON-SIEMENS SYSTEM) WHICH GENERATED A PT/INT RESULT OF "NO CLOT DETECTED" AND AN INR RESULT OF >9.0 WAS REPORTED TO THE PHYSICIAN. A DIFFERENT SAMPLE (SAMPLE 2) FROM THE PATIENT WAS RUN ON THE SAME CA-660 ANALYZER AND A PT/INR RESULT OF 25.2 SECONDS/ INR 2.46 WAS GENERATED. THE SAME SAMPLE WAS RUN AGAIN ON THE SAME SYSMEX CA-660 ANALYZER AND A SIMILAR RESULT WAS GENERATED. THE PT/INR RESULT OF 25.2 SECONDS/ INR 2.46 WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. SAMPLE 1 WAS RERUN AGAIN (3) THREE MORE TIMES ON THE CA-660 ANALYZER GENERATING PT/INR RESULTS SIMILAR TO RESULTS GENERATED BY SAMPLE 2. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7227159 ↗
• MalfunctionDec 28, 2017Mechanical Problem; Incorrect Or Inadequate Test Results; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Incorrect Or Inadequate Test Results; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS, DISCORDANT, FALSELY ELEVATED PT INTERNATIONAL NORMALIZED RATIO (INR) RESULTS, AND DISCORDANT, FALSELY LOW PT % RESULTS WERE OBTAINED ON 3 PATIENT SAMPLES ON THE SYSMEX CS-2100I SYSTEM. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED THE PHYSICIAN(S). THE SAME SAMPLES WERE RERUN ON AN ALTERNATE SYSTEM, SYSMEX CA-660 SYSTEM, USING THE SAME REAGENT LOT, AND THE SAME SYSTEM, RESULTING IN LOWER PT RESULTS AND PT INR RESULTS AND HIGHER PT% RESULTS. IT IS UNKNOWN IF THE REPEATED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PT RESULTS, DISCORDANT, FALSELY ELEVATED PT INR RESULTS, AND DISCORDANT, FALSELY LOW PT % RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7152272 ↗
• MalfunctionDec 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FLAGGED, NON-NUMERICAL PROTHROMBIN TIME (PT) RESULT OF "ERR999 ANALYSIS FAILED" AND "SAMPLE PROBE SAMPLING ERROR" WAS OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CA-1500 SYSTEM. THE SAME SAMPLE WAS RERUN ON THE SAME SYSTEM, RESULTING IN ANOTHER NON-NUMERICAL FLAGGED RESULT OF "ERR032 NO COAGULATION". THE SAME SAMPLE WAS REPEATED ON THE SAME SYSTEM, RESULTING IN A DISCORDANT, FALSELY ELEVATED PT RESULT. THIS RESULT WAS REPORTED TO THE NURSE, WHO QUESTIONED THE RESULT AS THE PATIENT WAS NOT ON COUMADIN MEDICATION. THE PATIENT'S BLOOD WAS REDRAWN AND RUN ON AN ALTERNATE SYSMEX CA-1500 SYSTEM, USING THE SAME REAGENT LOT, RESULTING LOWER. THE INITIAL SAMPLE WAS RERUN ON THE ALTERNATE SYSTEM, RESULTING LOWER. THE REPEAT RESULT OF 10.7 SECONDS WAS PROVIDED TO THE PHYSICIAN AS A CORRECTION TO THE DISCORDANT RESULT. THE RESULTS OBTAINED ON THE ALTERNATE SYSTEM ALIGNED WITH THE PATIENT'S CLINICAL HISTORY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7152260 ↗
• MalfunctionDec 28, 2017Mechanical Problem; Incorrect Or Inadequate Test Results; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Incorrect Or Inadequate Test Results; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT, A DISCORDANT, FALSELY ELEVATED PT INTERNATIONAL NORMALIZED RATIO (INR) RESULT, AND A DISCORDANT, FALSELY LOW PT % RESULT WERE OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CS-2100I SYSTEM. THESE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. DUE TO THE DISCORDANT RESULTS, THE PATIENT WAS ADMINISTERED AN ADDITIONAL DOSAGE OF VITAMIN K. THE PATIENT'S BLOOD WAS REDRAWN AND RUN ON THE SAME SYSTEM, RESULTING IN A LOWER PT RESULT, A LOWER PT INR RESULT AND HIGHER PT% RESULT. ON (B)(6) 2017, THE INITIAL SAMPLE WAS RERUN ON THE SAME SYSTEM, IN DUPLICATE, RESULTING IN LOWER PT RESULTS, LOWER PT INR RESULTS AND HIGHER PT% RESULTS THAN THE INITIAL RESULTS. A CORRECTED REPORT WAS PROVIDED TO THE PHYSICIAN(S), BUT THE RESULTS IN THE CORRECTED REPORT ARE UNKNOWN. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PT RESULT, DISCORDANT, FALSELY ELEVATED PT INR RESULT, AND DISCORDANT, FALSELY LOW PT % RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7152259 ↗
• MalfunctionDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT PROTHROMBIN TIME (PT) RESULTS AND PT INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON 13 PATIENT SAMPLES ON THE SYSMEX CA-1500 SYSTEM. THESE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. AT LEAST 4 OF THE 13 SAMPLES WERE RUN ON THIS SYSTEM WHEN QUALITY CONTROL RESULTS RECOVERED OUT OF RANGE. THE AFFECTED PATIENTS WERE REDRAWN AND RUN ON THE SAME SYSTEM AFTER THE CUSTOMER RECONSTITUTED THE QUALITY CONTROLS AND REAGENT, RESULTING IN EXPECTED RESULTS. CORRECTED REPORTS WERE PROVIDED TO THE PHYSICIAN(S) FOR THE AFFECTED PATIENTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PT RESULTS AND PT INR RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7110191 ↗
• MalfunctionNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT AND A DISCORDANT, FALSELY ELEVATED PT INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED ON A PATIENT SAMPLE TUBE ON THE SYSMEX CA-560 SYSTEM. THESE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULTS. THE SAME SAMPLE WAS TRANSFERRED TO A SAMPLE CUP AND RERUN ON THE SAME SYSTEM, RESULTING LOWER. THE PATIENT'S BLOOD WAS REDRAWN AND RUN IN A PRIMARY TUBE AND IN A SAMPLE CUP ON THE SAME SYSTEM, RESULTING LOWER THAN THE INITIAL RESULTS. THE RESULTS OBTAINED ON THE REDRAWN SAMPLE TUBE WERE REPORTED TO THE PHYSICIAN. 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 7068669 ↗
• MalfunctionNov 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FLAGGED NON-NUMERICAL PROTHROMBIN TIME (PT) RESULTS AND PT INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON THE SYSMEX CA-1500 SYSTEM. THE SAME SAMPLES WERE AUTOMATICALLY REPEATED ON THE SAME SYSTEM. A DISCORDANT, FALSELY LOW PT RESULT AND A DISCORDANT, FALSELY LOW PT INR RESULT WERE OBTAINED ON ONE PATIENT SAMPLE (SAMPLE ID (SID) (B)(6)), WHEREAS NON-NUMERICAL, FLAGGED RESULTS WERE OBTAINED ON THE OTHER PATIENT SAMPLE (SID: (B)(6)). THE SYSTEM AUTOMATICALLY VALIDATED THE DISCORDANT LOW RESULTS AND THE RESULTS WERE SENT TO THE LABORATORY INFORMATION SYSTEM (LIS) FOR SID (B)(6). THE LIS AUTO VALIDATED AND REPORTED THE DISCORDANT RESULTS TO THE PHYSICIAN. THE PHYSICIAN DID NOT QUESTION THE RESULTS SINCE THE RESULTS WERE CORRECTED BY THE LAB IN A TIMELY MANNER. NO DISCORDANT RESULTS WERE REPORTED ON THE OTHER PATIENT SAMPLE (SID (B)(6)). THE CUSTOMER REALIZED THAT PATIENT SAMPLE SID (B)(6) WAS NOT SPUN PRIOR TO RUNNING THE PT TEST. BOTH SAMPLES WERE SPUN AND REPEATED ON THE SAME SYSTEM AND EXPECTED RESULTS WERE OBTAINED. CORRECTED FINAL REPORTS WERE PROVIDED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7053213 ↗
• MalfunctionNov 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULT AND A DISCORDANT, FALSELY ELEVATED PT INTERNATIONAL NORMALIZED RATIO (INR) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CA-660 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULTS. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER), WHERE THE PATIENT'S BLOOD WAS REDRAWN AND RUN ON THE SAME SYSTEM, RESULTING LOWER. THE REPEATED RESULTS WERE PROVIDED TO THE PHYSICIAN. THE ORIGINAL SAMPLE WAS ALSO RERUN ON THE SAME SYSTEM, RESULTING LOWER THAN THE INITIAL RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7040639 ↗
• MalfunctionOct 20, 2017High Test Results; High Test Results

  A DISCORDANT, HIGH PROTHROMBIN TIME / INTERNATIONAL NORMALIZED RATIO (PT/INR) PATIENT SAMPLE RESULT OF 61.9 SECONDS/ 5.85 INR WAS GENERATED ON A CA-660 ANALYZER. THE DISCORDANT, HIGH PT/INR RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. ANOTHER TWO SAMPLES (SAMPLES 2 AND 3) WERE DRAWN FROM THE PATIENT AND RUN ON THE SAME CA-660 ANALYZER. LOWER PT/INR RESULTS WERE GENERATED. IN ADDITION, THE ORIGINAL SAMPLE WAS RERUN ON THE SAME SYSTEM AND ALSO GENERATED A LOWER PT/INR RESULT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, HIGH PT/INR RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6964422 ↗
• MalfunctionOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY ELEVATED PROTHROMBIN TIME (PT) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON THE SYSMEX CA-1500 SYSTEM. THE CUSTOMER REPORTED A DISCORDANT, FALSELY ELEVATED PT RESULT ON ONE PATIENT SAMPLE (SID PATIENT 1) TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. BASED ON THE DISCORDANT RESULT, THE PATIENT WAS SENT TO THE EMERGENCY ROOM AND THE PATIENT BLOOD WAS REDRAWN AND TESTED FOR PT, RESULTING IN THE NORMAL RANGE. THE INITIAL PATIENT SAMPLE WAS ALSO RERUN ON THE SAME SYSTEM, RESULTING LOWER. A CORRECTED REPORT WAS PROVIDED TO THE PHYSICIAN. THE CUSTOMER DID NOT REPORT ANY DISCORDANT RESULTS ON THE SECOND PATIENT SAMPLE (SID (B)(6)) AND RERAN THE PATIENT SAMPLE TWICE ON THE SAME SYSTEM, RESULTING LOWER THAN THE INITIAL RESULTS. THE SAME PATIENT SAMPLE WAS ALSO RERUN ON AN ALTERNATE SYSMEX CA-1500 SYSTEM, RESULTING LOWER. A REPEATED RESULT WAS REPORTED TO THE PHYSICIAN AS IT MATCHED THE PATIENT'S CLINICAL HISTORY. THE CUSTOMER INDICATED THAT THE SAMPLES WERE NEITHER HEMOLYZED, LIPEMIC, ICTERIC NOR CLOTTED AND THAT THE SAMPLES WERE APPROPRIATELY FILLED FOR BOTH PATIENTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6937213 ↗