Triage 97300EURecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 30014613337959), received between Mar 4, 2021 and Feb 6, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Low Test Results

  THE LAB GOT A COMPLAINT FROM CARDIOLOGIST REGARDING THE SOB PANEL RESULTS WERE WITHIN THE NORMAL RANGE BUT IT DID NOT CORRESPOND TO THE PATIENT'S CLINICAL CONDITION. PATIENT INFORMATION: MALE, 79 YEARS OLD. SX: CHEST PAIN DX: AMI BASED ON ECG AND HS TROP T RESULTS, ABNORMAL LATERAL ST FROM EKG; TREATMENT PERFORMED BASED OFF LAB ANALYZER METHOD.

  Patient problems: Chest Pain; Myocardial Infarction; Non specific EKG/ECG Changes

  MAUDE report 24284796 ↗
• MalfunctionFeb 6, 2026Non Reproducible Results

  LOT: T16075. CUSTOMER REPORTED CONFLICTING RESULTS ON TRIAGE D-DIMER TEST ON ONE PATIENT. NO FURTHER PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284795 ↗
• MalfunctionJul 17, 2025High Test Results; High Test Results

  CUSTOMER REPORTED CONFLICTING TNI RESULTS ON TRIAGE SOB COMPARED TO TRIAGE TROPONIN I RESULTS AND A RERUN ON SOB. PATIENT AT RESTING ECG, ECHOCARDIOGRAPHY AND STRESS ECHOCARDIOGRAPHY WERE IN NORMAL RANGE. PATIENT WAS SENT HOME, NO OTHER TREATMENT WAS MENTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22533076 ↗
• MalfunctionJul 10, 2025High Test Results; High Test Results

  CUSTOMER REPORTED CONFLICTING TNI RESULTS ON SOB COMPARED TO RESULTS RE-RUNNING THE SAME DEVICE IN THE SAME METER AND ANOTHER METER AND REDRAW AND RETESTING ON ANOTHER SOB DEVICE. PATIENT HAD NO SYMPTOMS SUCH AS CHEST PAIN AND DYSPNEA. THE PATIENT NEEDED TO BE HOSPITALIZED FOR PHYSICAL EXAMINATION, ECG WAS NORMAL AT THE TIME OF ADMISSION, NO OTHER TREATMENT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22471093 ↗
• MalfunctionMay 21, 2025Low Test Results; Low Test Results

  CUSTOMER REPORTED DISCREPANT LOW TNI RESULTS FOR ONE PATIENT VS. UNKNOWN LABORATORY HS-TNI METHOD. PATIENT SYMPTOMS: SUPRAVENTRICULAR TACHYCARDIA, MILD DYSPNEA, NO AP. PATIENT DIAGNOSIS AND TREATMENT: FIRST RHYTHMIZATION, THEN BECAUSE OF TROP INCREASE, HK WITH EVIDENCE OF 1-CHK, STENT IMPLANTATION.

  Patient problems: Dyspnea; Tachycardia

  MAUDE report 22065021 ↗
• MalfunctionMay 13, 2025High Test Results; High Test Results

  CUSTOMER REPORTED A DISCREPANT HIGH TNI RESULT FOR ONE PATIENT ON TRIAGE SOB VS. VIDAS PATIENT SYMPTOMS AND DIAGNOSIS ARE UNKNOWN. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011817 ↗
• MalfunctionFeb 20, 2025Low Test Results; Low Test Results

  DISCREPANT LOW RESULTS FOR TNI WITH TRIAGE SOB VS LAB TNT. SX: SYMPTOMATIC, DX.: CORONARY 2/ TWO VESSEL DISEASE, TREATMENT: PATIENT WAS TRANSFERRED TO HOSPITAL STATIONARY, GOT 2 X CORONARY ANGIOGRAPHIES.

  Patient problems: Ischemic Heart Disease

  MAUDE report 21423183 ↗
• MalfunctionMar 4, 2021High Test Results

  CUSTOMER REPORTED A PATIENT AFTER PULMONARY EMBOLISM WAS TESTED FOR D-DIMER ON TRIAGE AND RESULTED ABNORMAL AT 1250NG/ML. LAB RESULT WITH SAMPLE TAKEN AT THE SAME TIME AS TRIAGE RESULT WAS NORMAL AT 560UG/L. CUTOFF FOR TRIAGE: 400NG/ML, CUTOFF FOR LAB ANALYZER: 590UG/L. THE TIMING BETWEEN PULMONARY EMBOLISM DIAGNOSIS AND TRIAGE TESTING EVENT WAS NOT PROVIDED.

  MAUDE report 11416728 ↗