ADVIA Centaur® iPTH 10492369Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00630414579160), received between Jun 14, 2017 and Dec 11, 2017 — classified as 4 malfunctions.

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 16, 2026.

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.

• MalfunctionDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT LOW RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON THE ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY. THE PHYSICIAN QUESTIONED THE RESULT AS A HIGHER RESULT WAS EXPECTED. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS HIGHER. CUSTOMER STATES PATIENT IS A DIALYSIS PATIENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT IPTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7106888 ↗
• MalfunctionOct 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER OBSERVED A ZERO RESULT FOR A PATIENT SAMPLE ON THE ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY AFTER CALIBRATION. THE CUSTOMER STATED THAT THE QUALITY CONTROL WAS IN RANGE AFTER THE CALIBRATION. THE ZERO RESULT WAS NOT REPORTED. THE CUSTOMER RECALIBRATED ON (B)(6) 2017 WITH A FRESH SET OF CALIBRATORS. THE QUALITY CONTROL WAS REPEATED AND THE VALUES WERE IN RANGE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS HIGHER. THE HIGHER RESULT WAS REPORTED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT IPTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976083 ↗
• MalfunctionAug 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT ADVIA CENTAUR XP IPTH RESULTS WERE OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE HAD A RESULT GREATER THAN 1900. THE SAMPLE WAS DILUTED (1:5) AND THE RESULTS WERE LOW. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THESE DISCORDANT IPTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6818896 ↗
• MalfunctionJun 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT ADVIA CENTAUR IPTH RESULTS WERE OBTAINED FOR SAMPLES FROM THE SAME PATIENT. THE PHYSICIAN QUESTIONED THE ELEVATED RESULTS. THE PHYSICIAN WAS EXPECTING NORMAL RESULTS SINCE THE PATIENT HAD NORMAL SCANS AND HAS NOT HAD SURGERY. THE CUSTOMER PERFORMED A DILUTION. THE DILUTION INDICATED A POTENTIAL INTERFERING SUBSTANCE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THESE DISCORDANT IPTH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6641074 ↗