HOST 2, EPOC HH-1009-00-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00809708052898), received between Feb 27, 2020 and May 23, 2023 — classified as 1 death, 6 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 12, 2022Open, Classified

   pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

   Z-1214-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2023No Device Output; No Device Output

  THE CUSTOMER IS ALLEGING THAT SIEMENS EPOC DEVICE FROZE DURING PATIENT TESTING. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16987023 ↗
• MalfunctionJan 25, 2021Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT HEMOGLOBIN RESULTS ON TWO PATIENTS ON THE EPOC READER WHEN COMPARED TO A NON-SIEMENS LAB ANALYZER. THE CUSTOMER INDICATED THAT PATIENT #2 IS DECEASED AND THAT PATIENT #1 WAS DISCHARGED. LIMITED INFORMATION WAS PROVIDED WITH THIS COMPLAINT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION TO BE SENT.

  Patient problems: Insufficient Information

  MAUDE report 11224249 ↗
• MalfunctionDec 10, 2020Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT HIGH PH RESULTS ON THE EPOC HOST WHEN COMPARED TO RESULTS ON ANOTHER SIEMENS LAB INSTRUMENT, THE RAPID LAB 1265. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: Abnormal Blood Gases

  MAUDE report 10984903 ↗
• DeathJul 23, 2020Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT SODIUM AND POTASSIUM RESULTS ON ONE PATIENT RUN ON THE EPOC SYSTEM TWICE AND THEN COMPARED TO A NON-SIEMENS LAB ANALYZER. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL DUE TO CARDIAC ARREST. THE PATIENT HAD A HISTORY OF ELECTROLYTE ABNORMALITIES. THE PATIENT LATER PASSED AWAY ON THE SAME DAY, (B)(6) 2020. THE CUSTOMER STATED THEY ARE NOT ALLEGING THAT THE EPOC DEVICE ATTRIBUTED TO THE PATIENT'S DEMISE.

  Patient problems: Sudden Cardiac Death

  MAUDE report 10315960 ↗
• MalfunctionJul 16, 2020Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT TOTAL HEMOGLOBIN RESULTS ON THE EPOC HOST WHEN COMPARED TO A NON-SIEMENS LAB INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10286296 ↗
• MalfunctionMar 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE EPOC HOST/READER DID NOT PROVIDE SAMPLE RESULTS FOR APPROXIMATELY FIVE DAYS ON A CRITICALLY ILL PATIENT. THE PATIENT IS DISEASED. THE SYSTEM APPEARS TO BE WORKING AS INTENDED BY GIVING ERROR MESSAGES TO INDICATE NO RESULTS COULD BE REPORTED.

  Patient problems: Death

  MAUDE report 9826159 ↗
• MalfunctionFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER STATED A NICU NURSE DREW A HEEL STICK SAMPLE AND RAN AN EPOC CAP-CARE TUBE, PT. ID# (B)(6). THE RESULTS WERE NOT TRANSFERRING OVER INTO THE PATIENT'S CHART (POWERCHART EMR), AND IT WAS THEN DISCOVERED THAT THE PATIENT HAD ANOTHER PATIENT WRISTBAND ON, PT. ID# (B)(6). THE INCORRECT BARCODE WAS SCANNED. THE PATIENT'S WRISTBAND WAS CORRECTED, BUT THE RESULTS IN THE EPOC AND EDM WERE STILL MISMATCHED TO ANOTHER PATIENT. THERE WERE NO LAB TESTS PERFORMED ON THE OTHER BABY. NO TREATMENT OR LACK OF TREATMENT OCCURRED AS A RESULT OF THE USER ERROR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765338 ↗