Aution™ Hybrid AU-4050 Chemical Analyzer 14603Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00015482146030), received between Feb 11, 2019 and Mar 29, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Patient Data Problem” (4 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. May 3, 2019Class IITerminated

   This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorrectly. 3) An item rack is used for subsequent sample measurements.

   Z-1850-2019 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2019Patient Data Problem; Patient Data Problem

  PATIENT HAD HER DEMOGRAPHICS ASSIGNED TO ANOTHER PATIENT'S SAMPLE RESULTS. SAMPLES WERE RUN WITHOUT QUERY TO THE LIS MEANING NO ORDER WAS RECEIVED FROM THE LIS AND THEREFORE NO ORDERS WITH PATIENT DEMOGRAPHICS. ON (B)(6) 2018 IT WAS FOUND THAT THREE SAMPLES WITHOUT QUERY AND THEREFORE ORDERS STILL HAD DEMOGRAPHICS ASSOCIATED WITH THEM ON BOTH THE ANALYZER PRINTOUT AND THE LIS TRANSMISSION AND IN ALL THREE CASES THOSE DEMOGRAPHICS WERE FOR THE INCORRECT PATIENTS (THREE PATIENTS LISTED ABOVE). IN NONE OF THESE CASES WERE THE PATIENTS MISDIAGNOSED OR MISTREATED. THE PATIENT RESULTS WERE CORRECTLY TIED TO THE CORRECT PATIENTS AT THE LIS BECAUSE THE LIS ALREADY HAS THE CORRECT DEMOGRAPHIC INFORMATION. DEMOGRAPHIC INFORMATION SENT BY THE ANALYZER WITH THE RESULTS IS IGNORED BY THE LIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8466042 ↗
• MalfunctionMar 29, 2019Patient Data Problem; Patient Data Problem

  PATIENT HAD HER DEMOGRAPHICS ASSIGNED TO ANOTHER PATIENT'S SAMPLE RESULTS. SAMPLES WERE RUN WITHOUT QUERY TO THE LIS MEANING NO ORDER WAS RECEIVED FROM THE LIS AND THEREFORE NO ORDERS WITH PATIENT DEMOGRAPHICS. ON (B)(6) 2018 IT WAS FOUND THAT THREE SAMPLES WITHOUT QUERY AND THEREFORE ORDERS STILL HAD DEMOGRAPHICS ASSOCIATED WITH THEM ON BOTH THE ANALYZER PRINTOUT AND THE LIS TRANSMISSION AND IN ALL THREE CASES THOSE DEMOGRAPHICS WERE FOR THE INCORRECT PATIENTS (THREE PATIENTS LISTED ABOVE). IN NONE OF THESE CASES WERE THE PATIENTS MISDIAGNOSED OR MISTREATED. THE PATIENT RESULTS WERE CORRECTLY TIED TO THE CORRECT PATIENTS AT THE LIS BECAUSE THE LIS ALREADY HAS THE CORRECT DEMOGRAPHIC INFORMATION. DEMOGRAPHIC INFORMATION SENT BY THE ANALYZER WITH THE RESULTS IS IGNORED BY THE LIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8466034 ↗
• MalfunctionFeb 11, 2019Patient Data Problem; Patient Data Problem

  PATIENT HAD HIS DEMOGRAPHICS ASSIGNED TO ANOTHER PATIENT'S SAMPLE RESULTS. SAMPLES WERE RUN WITHOUT QUERY TO THE LIS MEANING NO ORDER WAS RECEIVED FROM THE LIS AND THEREFORE NO ORDERS WITH PATIENT DEMOGRAPHICS. ON (B)(6) 2018 IT WAS FOUND THAT THREE SAMPLES WITHOUT QUERY AND THEREFORE ORDERS STILL HAD DEMOGRAPHICS ASSOCIATED WITH THEM ON BOTH THE ANALYZER PRINTOUT AND THE LIS TRANSMISSION AND IN ALL THREE CASES THOSE DEMOGRAPHICS WERE FOR THE INCORRECT PATIENTS (THREE PATIENTS LISTED ABOVE). IN NONE OF THESE CASES WERE THE PATIENTS MISDIAGNOSED OR MISTREATED. THE PATIENT RESULTS WERE CORRECTLY TIED TO THE CORRECT PATIENTS AT THE LIS BECAUSE THE LIS ALREADY HAS THE CORRECT DEMOGRAPHIC INFORMATION. DEMOGRAPHIC INFORMATION SENT BY THE ANALYZER WITH THE RESULTS IS IGNORED BY THE LIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8326305 ↗
• MalfunctionFeb 11, 2019Patient Data Problem; Patient Data Problem

  PATIENT HAD HER DEMOGRAPHICS ASSIGNED TO ANOTHER PATIENT'S SAMPLE RESULTS. THE CUSTOMER CLAIMS THE SAME INCORRECT PATIENT DEMOGRAPHICS ARE SHOWN IN THE IPU SOFTWARE. PER THE CUSTOMER NO ACTION WAS TAKEN IN TREATMENT OF THE PATIENT INCORRECTLY IDENTIFIED BASED ON THESE RESULTS HAVING THE PATIENT'S DEMOGRAPHICS TIED TO THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8326272 ↗