Automated Blood Coagulation Analyzer CS-2500 BV981798Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04987562433735), received between Jan 10, 2019 and Jul 25, 2024 — classified as 1 death, 7 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathJul 25, 2024Use of Device Problem; Use of Device Problem

  AN OPERATOR MISINTERPRETED THE ACTIVATED PARTIAL THROMBOPLASTIN TIME COAGULATION CURVE GENERATED BY THE ANALYZER. ERRONEOUS RESULTS WERE REPORTED. PATIENT RECEIVED UNNECESSARY HEPARIN TREATMENT AND EXPIRED DUE TO CONSEQUENCES OF INTERNAL BLEEDING AND OTHER CLINICAL SIGNS AND SYMPTOMS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 19827370 ↗
• InjuryApr 13, 2022Low Test Results; Low Test Results

  THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2022, WITH ELEVATED TEMPERATURE AND LEG PAIN. A SAMPLE FOR D-DIMER TESTING WAS COLLECTED AND SUBMITTED FOR ANALYSIS. THE RESULT GENERATED WAS NORMAL. THE PATIENT WAS DISCHARGED. THE PATIENT'S SAMPLE WAS REPEATED LATER THE SAME DAY FOR LAB CORRELATION STUDIES. REPEAT ANALYSIS GENERATED ELEVATED D-DIMER RESULTS. THE PATIENT WAS RECALLED FOR COLLECTION OF A REPEAT SAMPLE THE FOLLOWING DAY. ANALYSIS OF THIS SAMPLE ALSO GENERATED ELEVATED D-DIMER TEST RESULTS. ADMINISTRATION OF TINZAPARIN WAS STARTED, ON (B)(6) 2022 (TIME NOT PROVIDED). ULTRASOUND (US) COMPRESSION VENOGRAPHY WAS SCHEDULED FOR THE FOLLOWING DAY. ON (B)(6) 2022 US COMPRESSION VENOGRAPHY CONCLUDED POSITIVE FOR CALF DEEP VEIN THROMBOSIS (DVT) AND ADMINISTRATION OF APIXABAN WAS STARTED (TIME NOT PROVIDED). PER THE USER, THE PATIENT EXPERIENCED A DELAY IN DIAGNOSTIC TESTING AND ANTICOAGULANT THERAPY DUE TO THE ERRONEOUS LOW D-DIMER RESULTS REPORTED. NO SERIOUS INJURY OR HARM TO THE PATIENT DUE TO THE DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14104394 ↗
• InjuryJul 27, 2021Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  AN ERRONEOUS HEPARIN RESULT WAS REPORTED TO THE MEDICAL TEAM. PRIOR TO THE INITIAL SAMPLE ANALYSIS, QUALITY CONTROL (QC) WAS ANALYZED GENERATING RESULTS WITHIN RANGE. THE OPERATOR CHANGED THE INNOVANCE HEPARIN REAGENT AND ANALYZED THE PATIENT SAMPLE. THE INITIAL ANALYSIS GENERATED AN ERROR CODE AND THE RESULT WAS REPORTED TO THE MEDICAL TEAM AS THE UPPER REPORTABLE RANGE LIMIT. NEXT, QC WAS ANALYZED AND GENERATED AN ERROR CODE. REANALYSIS GENERATED QC RESULTS THAT WERE OUT OF RANGE. THE REAGENT WAS CHANGED AND QC WAS ANALYZED GENERATING RESULTS OUT OF RANGE. A NEW VIAL OF QC WAS ANALYZED GENERATING RESULTS WITHIN RANGE. THE PATIENT SAMPLE WAS REANALYZED GENERATING AN ACCURATE HEPARIN RESULT. ADDITIONALLY, THE RESULT WAS VERIFIED ON A SECOND ANALYZER. A CORRECTED REPORT WAS ISSUED. THE PATIENT'S HEPARIN TREATMENT WAS STOPPED DUE TO THE ERRONEOUS RESULT. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229687 ↗
• InjuryApr 7, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  MULTIPLE SAMPLES FROM THE SAME PATIENT WERE ANALYZED FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) AND GENERATED RESULTS WITH ASTERISKS. THE OPERATOR REVIEWED THE COAGULATION CURVE AND REPORTED A NUMERICAL VALUE FOR THE APTT RESULT. THE OPERATOR REPORTED A FALSELY DECREASED APTT RESULT ON AN ANALYSIS THAT GENERATED ERROR CODE 0008.0128.002: [EARLY REACTION ERROR: START ANGLE 1]. THE PATIENT WAS RECEIVING INTRAVENOUS HEPARIN TREATMENT AND THE TREATMENT CONTINUED BASED ON THE ERRONEOUS APTT RESULT. THERE WAS NO HARM TO THE PATIENT REPORTED DUE TO THE PROLONGED HEPARIN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11631167 ↗
• InjuryApr 8, 2020Use of Device Problem; Use of Device Problem

  THE SAMPLE WAS ANALYZED FOR AN ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT). NO NUMERICAL VALUE WAS GENERATED WITH AN "EARLY REACTION ERROR (EARLY %)". THE USER REVIEWED THE COAGULATION CURVE AND REPORTED A NUMERICAL VALUE FOR THE APTT. THE PATIENT'S THERAPY WAS CHANGED FROM HEPARIN TO ARGATROBAN BASED ON THE NUMERICAL RESULT. NO PATIENT HARM WAS REPORTED BASED ON THE ADMINISTRATION OF ARGATROBAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9935571 ↗
• InjuryDec 11, 2019Use of Device Problem; Use of Device Problem

  MULTIPLE SAMPLES FROM THE SAME PATIENT WERE ANALYZED BETWEEN (B)(6) 2019 AND (B)(6) 2019. MOST SAMPLES GENERATED THE "NO COAGULATION" OR "FLAT CURVE" ERRORS WITH NO NUMERICAL VALUES FOR THE PROTHROMBIN TIME (PT) RESULTS. THE USER REPORTED PT RESULTS OF >100 SECONDS. THE PATIENT WAS REFERRED TO ANOTHER FACILITY AFTER (B)(6) 2019 AND NORMAL PT RESULTS WERE GENERATED FROM SUBSEQUENT SAMPLES. THE PATIENT RECEIVED VITAMIN K TREATMENT BASED ON THE ERRONEOUS PT RESULTS. IT IS UNKNOWN WHEN THE VITAMIN K TREATMENT WAS ADMINISTERED. NO PATIENT HARM WAS REPORTED BASED ON THE ADMINISTRATION OF VITAMIN K.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9454156 ↗
• InjuryMar 28, 2019Use of Device Problem; Use of Device Problem

  A SAMPLE WAS ANALYZED FOR AN ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT). THE ANALYZER GENERATED "EARLY REACTION ERROR: SLOW REACTION" AND "EARLY REACTION ERROR: EARLY %" ERRORS. THE RESULT WAS DISPLAYED AS ASTERISKS [*]. THE USER REPORTED AN APTT RESULT BASED ON THE 50% COAGULATION TIME VALUE GENERATED BY THE ANALYZER. THE PHYSICIAN ADMINISTERED HEPARIN DUE TO THE RESULT. THE DOSAGE IS UNKNOWN. AN ADDITIONAL SAMPLE WAS COLLECTED AND SENT TO A REFERENCE LAB FOR TESTING. THE REFERENCE LABORATORY GENERATED AN APTT RESULT OF >400 SECONDS (SEC). THREE SUBSEQUENT SAMPLES FROM THE SAME PATIENT WERE ANALYZED FOR AN APTT ON THE SAME DAY. ALL SAMPLES GENERATED "EARLY REACTION ERROR: EARLY %", "EARLY REACTION ERROR: SLOW REACTION", AND/OR "WAVE CHANGED 800NM" ERRORS. ALL APTT RESULTS WERE DISPLAYED AS ASTERISKS. THE USER REPORTED APTT RESULTS FOR ALL SAMPLES BASED ON THE 50% COAGULATION TIME VALUE GENERATED BY THE ANALYZER. ERRONEOUS APTT RESULTS WERE REPORTED. THE CORRECT APTT VALUES ARE UNKNOWN. IT IS UNKNOWN IF CORRECTED REPORTS WERE ISSUED. THE PATIENT RECEIVED UNNECESSARY HEPARIN ADMINISTRATION DUE TO THE RESULT REPORTED FOR THE FIRST SAMPLE. NO HARM WAS REPORTED DUE TO HEPARIN ADMINIS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8461647 ↗
• InjuryJan 10, 2019Misconnection; Improper or Incorrect Procedure or Method; Misconnection; Improper or Incorrect Procedure or Method

  THE USER REPORTED SALINE WAS ERRONEOUSLY CONNECTED TO THE ANALYZER INSTEAD OF RINSE WATER. THE USER REPORTED THAT QUALITY CONTROL (QC) RESULTS WERE IN RANGE WHEN SALINE WAS IN USE AND THAT PATIENT RESULTS WERE REPORTED FOR PROTHROMBIN TIME (PT) / INTERNATIONAL NORMALIZED RATIO (INR). THE LABORATORY INSTALLED AND PRIMED THE RINSE WATER THE FOLLOWING DAY AND REPEATED THE AFFECTED SAMPLES. ONE DISCORDANT PT/INR RESULT FOR A PATIENT ON ANTICOAGULANT THERAPY WAS FOUND. THE INITIAL SAMPLE HAD BEEN REPORTED WITH FALSELY ELEVATED PT/INR RESULTS. UPON FURTHER REVIEW OF THE ORIGINAL RESULT, THE LABORATORY FOUND THERE HAD BEEN AN INDICATION OF A "LOW DEFECTIVE SAMPLING ERROR". THE PATIENT'S ANTICOAGULANT DOSAGE HAD BEEN CHANGED BASED ON THE INCORRECT RESULT. ANTICOAGULANT THERAPY DOSAGE PRIOR TO THE EVENT AND IN RESPONSE TO THE EVENT WAS NOT PROVIDED. THE REPEAT ANALYSIS OF THE SAMPLE PRODUCED PT/INR RESULTS THAT WERE CONSISTENT WITH THE PATIENT'S PRIOR HISTORY. THE PATIENT RETURNED FOR PT/INR TESTING FOUR DAYS AFTER THE INITIAL COLLECTION. TEST RESULTS OBTAINED ON THIS SAMPLE WERE DECREASED, COMPARED TO THE REPEAT TESTING OF THE INITIAL SAMPLE. THERE WAS NO REPORT OF PATIENT HARM DUE TO THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8236999 ↗