Hemochron Whole Blood Microcoagulation System ELITERecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10711234510018), received between Nov 29, 2017 and Jul 1, 2025 — classified as 2 deaths, 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• DeathJul 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE ANALYZER WAS USED ON SEVERAL PATIENT CASES WHERE THEY OBSERVED UNEXPECTED RESULTS. THESE CASES INVOLVED PATIENTS WHO WENT INTO ARREST. ONE PATIENT COULD NOT BE RESUSCITATED, RESULTING IN DEATH. NO ADDITIONAL DETAILS OR PATIENT INFORMATION ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22375004 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE ANALYZER AND LOW RANGE ACT ASSAY WAS USED IN THE CATH LAB FOR MONITORING HEPARIN DURING AN UNSPECIFIED PROCEDURE. TARGET ACT WAS 245-250 SEC. NO BASELINE ACT MEASUREMENT WAS DONE. DURING THE PROCEDURE, A CLOT WAS OBSERVED ON THE GUIDE WIRE WHICH WAS SUCESSFULLY TREATED WITH THROMBOLYTIC THERAPY. THE END USER EXPRESSED CONCERN THAT THE HEMOCHRON SIGNATURE ELITE POSSIBLY OVERESTIMATED THE ACT RESULT THEREBY LEADING TO POSSIBLE UNDER HEPARINIZATION OF THE PATIENT. THE PHYSICIAN CLAIMED THE PATIENT HAD A MINOR MYOCARDIAL INFARCTION DUE TO CLOT MIGRATION. THE PATIENT WAS DISCHARGED IN GOOD CONDITION. NO PATIENT INFORMATION OTHER THAN BODY WEIGHT (184.97 LBS.) HAS BEEN PROVIDED. NO INFORMATION IS AVAILABLE REGARDING COMORBID CONDITIONS OR PAST HEALTH HISTORY.

  Patient problems: Myocardial Infarction

  MAUDE report 18984075 ↗
• DeathDec 3, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE ANALYZER AND LOW-RANGE ACT ASSAY REPORTED AN OUT-OF-RANGE HIGH PATIENT RESULT DURING AN EMERGENCY CARDIAC CATHETERIZATION PROCEDURE FOR A STEMI. AT AN UNSPECIFIED TIME BEFORE THE PROCEDURE, THE PATIENT WAS STARTED ON AN IV HEPARIN DRIP AT A RATE OF 21.9 ML/HOUR THAT DELIVERED AN UNSPECIFIED DOSAGE. THE FIRST ACT RESULT REPORTED BY THE HEMOCHRON SIGNATURE ELITE ANALYZER WAS 144 SECONDS, BELOW THE ACT TARGET RANGE OF 250-350 SECONDS (ESTABLISHED BY THE USER). A 3,000 UNIT IV HEPARIN BOLUS WAS GIVEN JUST BEFORE THE PROCEDURE BEGAN. THE SECOND ACT RESULT REPORTED 16 MINUTES AFTER THE FIRST RESULT WAS OUT-OF-RANGE HIGH. THIS WAS INTERPRETED TO SIGNIFY AN ACT VALUE ABOVE THE MEASURING RANGE (>400 SECONDS). NO HEPARIN WAS ADMINISTERED AT THAT TIME. THE LAST ACT RESULT REPORTED AN HOUR LATER WAS 176 SECONDS, WHICH WAS BELOW THE TARGET RANGE OF 250-350 SECONDS. RIGHT AFTER THE LAST ACT RESULT WAS REPORTED, A CODE BLUE OCCURRED. DESPITE RESUSCITATION EFFORTS LASTING 30 MINUTES BY PERSONNEL IN THE CATH LAB, THE PATIENT WAS PRONOUNCED DEAD. AN INVESTIGATION WAS PERFORMED. HEALTHCARE PROFESSIONALS INVOLVED IN THE PROCEDURE WERE I

  Patient problems: Death

  MAUDE report 9403598 ↗
• MalfunctionDec 27, 2018Low Test Results; Low Test Results

  FOLLOW-UP #1.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8201757 ↗
• MalfunctionDec 20, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  FOLLOW-UP #1.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8186223 ↗
• MalfunctionJul 18, 2018High Test Results; High Test Results

  HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE AND LOW-RANGE ACT SYSTEM REPORTED HIGHER THAN EXPECTED ACT RESULTS DURING A PCI PROCEDURE AND CORONARY STENT PLACEMENT. THE PATIENT WAS RECEIVING INTRAVENOUS HEPARIN WITH A TARGET ACT OF >250 SECONDS. ONE BLOOD SAMPLE GENERATED AN ACT RESULT THAT WAS 173 SECONDS, WHICH WAS A LOWER THAN EXPECTED RESULT. A BOLUS DOSE OF HEPARIN WAS GIVEN AND ANOTHER BLOOD SAMPLE DRAWN 9 MINUTES LATER GENERATED AN ACT RESULT OF 344 SECONDS, WHICH WAS A HIGHER THAN EXPECTED RESULT. THE HEPARIN INFUSION WAS DISCONTINUED AND A REPEAT BLOOD SAMPLE DRAWN 38 MINUTES LATER WAS 161 SECONDS. THIS RESULT WAS USED FOR PATIENT MANAGEMENT AND HEPARIN ADMINISTRATION WAS RESUMED. THE HEMOCHRON SIGNATURE ELITE AND LOW-RANGE ACT SYSTEM PASSED ELECTRONIC AND LIQUID QC BEFORE THE PROCEDURE. NO BLEEDING WAS REPORTED DURING THE PROCEDURE.

  Patient problems: Missing Value Reason; No Known Impact Or Consequence To Patient

  MAUDE report 7701019 ↗
• MalfunctionJul 18, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE AND LOW-RANGE ACT SYSTEM REPORTED INCONSISTENT ACT RESULTS DURING A PCI AND CRYOABLATION PROCEDURE. THE PATIENT RECEIVED AN INTRAVENOUS BOLUS DOSE OF HEPARIN WITH AN ACT TARGET RANGE THAT WAS UNSPECIFIED. THE FIRST 2 BLOOD SAMPLES GENERATED ACT RESULTS OF 180 AND 176 SECONDS, RESPECTIVELY, WHICH WERE LOWER THAN THE EXPECTED RESULTS. ANOTHER BLOOD SAMPLE WAS IMMEDIATELY DRAWN AND WAS RUN ON A SECOND HEMOCHRON SIGNATURE ELITE INSTRUMENT, WHICH GENERATED AN ACT >400 SECONDS, WHICH WAS AN EXPECTED RESULT. THE SECOND SIGNATURE ELITE INSTRUMENT WAS USED FOR ACT TESTING UNTIL THE PROCEDURE WAS COMPLETED. ALL ACT RESULTS WERE AS EXPECTED AND WERE USED FOR PATIENT MANAGEMENT. NO MEDICAL COMPLICATIONS WERE REPORTED. THE HEMOCHRON SIGNATURE ELITE AND LOW-RANGE ACT SYSTEM PASSED ELECTRONIC AND LIQUID QC BEFORE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7701013 ↗
• MalfunctionJul 18, 2018High Test Results; High Test Results

  HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE AND LOW-RANGE ACT SYSTEM REPORTED HIGHER THAN EXPECTED ACT RESULTS DURING A PCI PROCEDURE. THE PATIENT WAS RECEIVING INTRAVENOUS HEPARIN WITH A TARGET ACT OF >250 SECONDS. ONE BLOOD SAMPLE GENERATED AN ACT RESULT THAT WAS >400 SECONDS, WHICH WAS A HIGHER THAN EXPECTED RESULT. ANOTHER BLOOD SAMPLE DRAWN 12 MINUTES WAS ASSAYED ON A SECOND HEMOCHRON SIGNATURE ELITE WITH THE SAME LOT OF REAGENT CUVETTES, WHICH GENERATED AN ACT RESULT OF 180 SECONDS, WHICH WAS AN EXPECTED RESULT. AN INTRAVENOUS BOLUS DOSE OF HEPARIN WAS ADMINISTERED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE HEMOCHRON SIGNATURE ELITE AND LOW-RANGE ACT SYSTEM PASSED ELECTRONIC AND LIQUID QC BEFORE THE PROCEDURE. NO BLEEDING OR MEDICAL COMPLICATIONS WERE REPORTED.

  Patient problems: Missing Value Reason; No Known Impact Or Consequence To Patient

  MAUDE report 7701010 ↗
• MalfunctionApr 27, 2018Low Test Results; Low Test Results

  DISTRIBUTOR OF ACCRIVA PRODUCTS FOR (B)(4) REPORTED A LOWER THAN EXPECTED ACT RESULT WITH A HEMOCHRON SIGNATURE ELITE AND ACT+ MICROCOAGULATION SYSTEM. DURING AN UNSPECIFIED PROCEDURE IN THE CATH LAB, THE PATIENT REPORTEDLY RECEIVED AN UNSPECIFIED BOLUS DOSE OF HEPARIN WITH A TARGET ACT OF 300 SECONDS. THE PATIENT'S INITIALS, AGE, GENDER AND WEIGHT WERE NOT SPECIFIED. THE TYPE OF PROCEDURE, ACT DRAW TIME(S) AND RESULTS, CONCOMITANT MEDICATIONS AND CLINICAL CIRCUMSTANCES OF THE CASE ARE UNKNOWN AT THE TIME OF THIS REPORT; HOWEVER, THIS INFORMATION HAS BEEN REQUESTED.

  Patient problems: Missing Value Reason

  MAUDE report 7470847 ↗
• MalfunctionJan 5, 2018High Test Results; High Test Results

  HEALTHCARE PROFESSIONAL REPORTED AN OUT OF RANGE HIGH READING WITH A HEMOCHRON SIGNATURE ELITE AND ACT PLUS SYSTEM. A PATIENT WITH CORONARY ARTERY DISEASE UNDERWENT AN FOUR-VESSEL CORONARY ARTERY BYPASS AND WAS RECEIVING INTRAVENOUS HEPARIN. THE TARGET ACT WAS 480 SECONDS. ACT RESULTS MEASURED DURING THE PROCEDURE WERE AS EXPECTED EXCEPT FOR A SINGLE OUT-OF-RANGE HIGH ERROR. THE SAME SAMPLE WAS ASSAYED ON A DIFFERENT SIGNATURE ELITE INSTRUMENT AND REPORTED AN ACT RESULT OF 687 SECONDS AND THIS RESULT WAS USED FOR PATIENT MANAGEMENT. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT AND NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7170036 ↗
• MalfunctionJan 5, 2018High Test Results; High Test Results

  HEALTHCARE PROFESSIONAL REPORTED AN OUT OF RANGE HIGH READING WITH A HEMOCHRON SIGNATURE ELITE AND ACT PLUS SYSTEM. A PATIENT WITH MITRAL INSUFFICIENCY UNDERWENT A MITRAL VALVE REPAIR AND WAS RECEIVING INTRAVENOUS HEPARIN. THE TARGET ACT WAS 480 SECONDS. ACT RESULTS MEASURED DURING THE PROCEDURE WERE AS EXPECTED EXCEPT FOR A SINGLE OUT-OF-RANGE HIGH ERROR. THE SAME SAMPLE WAS ASSAYED ON A DIFFERENT SIGNATURE ELITE INSTRUMENT AND AN ACT RESULT OF 549 SECONDS WAS REPORTED. THIS RESULT WAS USED FOR PATIENT MANAGEMENT. THE PROCEDURE WAS COMPLETED WITHOUR INCIDENT AND NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7170027 ↗
• MalfunctionJan 2, 2018High Test Results; High Test Results

  HEALTHCARE PROFESSIONAL REPORTED OUT OF RANGE HIGH READINGS WITH A HEMOCHRON SIGNATURE ELITE AND ACT PLUS SYSTEM. A PATIENT WITH AORTIC STENOSIS UNDERWENT AN AORTIC VALVE REPLACEMENT AND WAS RECEIVING INTRAVENOUS HEPARIN. THE TARGET ACT WAS 480 SECONDS. ACT RESULTS REPORTED DURING THE PROCEDURE WERE AS EXPECTED EXCEPT FOR A SINGLE OUT-OF-RANGE HIGH ERROR. THE SAME SAMPLE ASSAYED ON A DIFFERENT SIGNATURE ELITE INSTRUMENT REPORTED AN ACT RESULT OF 507 SECONDS AND THIS RESULT WAS USED FOR PATIENT MANAGEMENT. THE PROCEDURE WAS COMPLETED AND NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7157220 ↗
• MalfunctionNov 29, 2017High Test Results; Low Test Results; High Test Results; Low Test Results

  FOLLOW-UP #1.

  Patient problems: Missing Value Reason; No Known Impact Or Consequence To Patient

  MAUDE report 7067867 ↗