ADVIA Centaur iPTHRecalls & reported problems across all models

We found 2 models of ADVIA Centaur iPTH by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2017 and May 24, 2018 — classified as 5 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Device Issue” (5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ADVIA Centaur iPTH problems

ADVIA Centaur iPTH models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ADVIA Centaur® iPTH 10492368

  RADIOIMMUNOASSAY, PARATHYROID HORMONE
  23 reports
• ADVIA Centaur® iPTH 10492369

  RADIOIMMUNOASSAY, PARATHYROID HORMONE
  4 reports

Recent ADVIA Centaur iPTH adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS REDRAWN THE FOLLOWING DAY AND THE RESULT WAS LOWER. THE CUSTOMER PERFORMED REPEAT IPTH TESTING OF THE ORIGINAL SAMPLE, THE REDRAWN SAMPLE, AND THE RESULTS WERE SIMILAR TO WHAT WAS ORIGINALLY OBTAINED. THE LOWER IPTH RESULT FROM THE REDRAWN SAMPLE WAS CONSIDERED TO BE CONSISTENT WITH THE PATIENT'S CLINICAL PICTURE. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP IPTH RESULTS. MDR 1219913-2018-00161 WAS FILED FOR A FALSELY ELEVATED REPEAT RESULT ON THE SAME PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7542237 ↗
• MalfunctionMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS REDRAWN THE FOLLOWING DAY AND THE RESULT WAS LOWER. THE CUSTOMER PERFORMED REPEAT IPTH TESTING OF THE ORIGINAL SAMPLE, THE REDRAWN SAMPLE, AND THE RESULTS WERE SIMILAR TO WHAT WAS ORIGINALLY OBTAINED. THE LOWER IPTH RESULT FROM THE REDRAWN SAMPLE WAS CONSIDERED TO BE CONSISTENT WITH THE PATIENT'S CLINICAL PICTURE. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP IPTH RESULTS. MDR 1219913-2018-00160 WAS FILED FOR A FALSELY ELEVATED INITIAL RESULT ON THE SAME PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7542229 ↗
• MalfunctionApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT HIGH RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON THE ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY. THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS LOWER. 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 7404718 ↗
• MalfunctionApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT HIGH RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON THE ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY. THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS LOWER. 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 7404713 ↗
• 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 ↗
• InjuryNov 16, 2017Device Issue; Device Issue

  A PATIENT SAMPLE ((B)(6) ) WAS TESTED FOR INTACT PARATHYROID HORMONE (IPTH) ON AN ADVIA CENTAUR XP INSTRUMENT ON (B)(6) 2016. THE RESULT WAS REPORTED TO THE PHYSICIAN. SAMPLES FROM THE PATIENT WERE ALSO TESTED FOR IPTH ON THE SAME INSTRUMENT ON (B)(6) 2017. THE CUSTOMER CONTACTED SIEMENS ON OCTOBER 19, 2017, AND STATED THAT A DOCTOR HAD QUESTIONED THE IPTH RESULTS AND STATED THAT UNNECESSARY SURGERY HAD BEEN PERFORMED DUE TO ALLEGED DISCORDANT IPTH RESULTS OUTSIDE OF THE CUSTOMER'S EXPECTED RANGE OF 14-72 PG/ML. THE PATIENT'S SAMPLES WERE NOT REPEATED AND NOT SENT OUT FOR TESTING TO CONFIRM WHETHER OR NOT THEY WERE DISCORDANT. OTHER THAN THE ALLEGED UNNECESSARY SURGERY, THERE HAVE BEEN NO REPORTS OF IMPACT TO THE PATIENT OR ADVERSE HEALTH CONSEQUENCES DUE TO ALLEGED IPTH DISCORDANT RESULTS. SIEMENS HAS CONTINUED TO FOLLOW UP WITH THE CUSTOMER AND REQUESTED ADDITIONAL INFORMATION REGARDING THE ALLEGED SURGERY. THE CUSTOMER ONLY KNOWS THAT SURGERY DECISIONS WERE MADE BASED ON THE DATA AND NOT AWARE OF ANY COMPLICATIONS OR ADVERSE EVENTS DUE TO SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO SIEMENS AND THE CUSTOMER DECLINES FURTHER FOLLOW UP ON THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038908 ↗
• InjuryNov 16, 2017Device Issue; Device Issue

  A PATIENT SAMPLE (SID (B)(6)) WAS TESTED FOR INTACT PARATHYROID HORMONE (IPTH) ON AN ADVIA CENTAUR XP INSTRUMENT ON (B)(6) 2017. THE RESULT WAS REPORTED TO THE PHYSICIAN. SAMPLES FROM THE PATIENT WERE ALSO TESTED FOR IPTH ON THE SAME INSTRUMENT ON (B)(6) 2016, (B)(6) 2017. THE CUSTOMER CONTACTED SIEMENS ON (B)(6) 2017, AND STATED THAT A DOCTOR HAD QUESTIONED THE IPTH RESULTS AND STATED THAT UNNECESSARY SURGERY HAD BEEN PERFORMED DUE TO ALLEGED DISCORDANT IPTH RESULTS OUTSIDE OF THE CUSTOMER'S EXPECTED RANGE OF 14-72 PG/ML. THE PATIENT'S SAMPLES WERE NOT REPEATED AND NOT SENT OUT FOR TESTING TO CONFIRM WHETHER OR NOT THEY WERE DISCORDANT. OTHER THAN THE ALLEGED UNNECESSARY SURGERY, THERE HAVE BEEN NO REPORTS OF IMPACT TO THE PATIENT OR ADVERSE HEALTH CONSEQUENCES DUE TO ALLEGED IPTH DISCORDANT RESULTS. SIEMENS HAS CONTINUED TO FOLLOW UP WITH THE CUSTOMER AND REQUESTED ADDITIONAL INFORMATION REGARDING THE ALLEGED SURGERY. THE CUSTOMER ONLY KNOWS THAT SURGERY DECISIONS WERE MADE BASED ON THE DATA AND NOT AWARE OF ANY COMPLICATIONS OR ADVERSE EVENTS DUE TO SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO SIEMENS AND THE CUSTOMER DECLINES FURTHER FOLLOW UP ON THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038881 ↗
• InjuryNov 16, 2017Device Issue; Device Issue

  A PATIENT SAMPLE (SID (B)(6)) WAS TESTED FOR INTACT PARATHYROID HORMONE (IPTH) ON AN ADVIA CENTAUR XP INSTRUMENT ON (B)(6) 2017. THE RESULT WAS REPORTED TO THE PHYSICIAN. SAMPLES FROM THE PATIENT WERE ALSO TESTED FOR IPTH ON THE SAME INSTRUMENT ON (B)(6) 2017. THE CUSTOMER CONTACTED SIEMENS ON OCTOBER 19, 2017, AND STATED THAT A DOCTOR HAD QUESTIONED THE IPTH RESULTS AND STATED THAT UNNECESSARY SURGERY HAD BEEN PERFORMED DUE TO ALLEGED DISCORDANT IPTH RESULTS OUTSIDE OF THE CUSTOMER'S EXPECTED RANGE OF 14-72 PG/ML. THE PATIENT'S SAMPLES WERE NOT REPEATED AND NOT SENT OUT FOR TESTING TO CONFIRM WHETHER OR NOT THEY WERE DISCORDANT. OTHER THAN THE ALLEGED UNNECESSARY SURGERY, THERE HAVE BEEN NO REPORTS OF IMPACT TO THE PATIENT OR ADVERSE HEALTH CONSEQUENCES DUE TO ALLEGED IPTH DISCORDANT RESULTS. SIEMENS HAS CONTINUED TO FOLLOW UP WITH THE CUSTOMER AND REQUESTED ADDITIONAL INFORMATION REGARDING THE ALLEGED SURGERY. THE CUSTOMER ONLY KNOWS THAT SURGERY DECISIONS WERE MADE BASED ON THE DATA AND NOT AWARE OF ANY COMPLICATIONS OR ADVERSE EVENTS DUE TO SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO SIEMENS AND THE CUSTOMER DECLINES FURTHER FOLLOW UP ON THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038865 ↗
• InjuryNov 16, 2017Device Issue; Device Issue

  A PATIENT SAMPLE (SID (B)(6)) WAS TESTED FOR INTACT PARATHYROID HORMONE (IPTH) ON AN ADVIA CENTAUR XP INSTRUMENT ON (B)(6) 2016. THE RESULT WAS REPORTED TO THE PHYSICIAN. SAMPLES FROM THE PATIENT WERE ALSO TESTED FOR IPTH ON THE SAME INSTRUMENT ON (B)(6) 2017. THE CUSTOMER CONTACTED SIEMENS ON (B)(6) 2017, AND STATED THAT A DOCTOR HAD QUESTIONED THE IPTH RESULTS AND STATED THAT UNNECESSARY SURGERY HAD BEEN PERFORMED DUE TO ALLEGED DISCORDANT IPTH RESULTS OUTSIDE OF THE CUSTOMER'S EXPECTED RANGE OF 14-72 PG/ML. THE PATIENT'S SAMPLES WERE NOT REPEATED AND NOT SENT OUT FOR TESTING TO CONFIRM WHETHER OR NOT THEY WERE DISCORDANT. OTHER THAN THE ALLEGED UNNECESSARY SURGERY, THERE HAVE BEEN NO REPORTS OF IMPACT TO THE PATIENT OR ADVERSE HEALTH CONSEQUENCES DUE TO ALLEGED IPTH DISCORDANT RESULTS. SIEMENS HAS CONTINUED TO FOLLOW UP WITH THE CUSTOMER AND REQUESTED ADDITIONAL INFORMATION REGARDING THE ALLEGED SURGERY. THE CUSTOMER ONLY KNOWS THAT SURGERY DECISIONS WERE MADE BASED ON THE DATA AND NOT AWARE OF ANY COMPLICATIONS OR ADVERSE EVENTS DUE TO SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO SIEMENS AND THE CUSTOMER DECLINES FURTHER FOLLOW UP ON THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038859 ↗
• InjuryNov 16, 2017Device Issue; Device Issue

  A PATIENT SAMPLE (SID (B)(6)) WAS TESTED FOR INTACT PARATHYROID HORMONE (IPTH) ON AN ADVIA CENTAUR XP INSTRUMENT ON (B)(6) 2017. THE RESULTS WERE REPORTED TO THE PHYSICIAN. SAMPLES FROM THE PATIENT WERE ALSO TESTED FOR IPTH ON THE SAME INSTRUMENT ON (B)(6) 2016, AND (B)(6) 2017. THE CUSTOMER CONTACTED SIEMENS ON OCTOBER 19, 2017, AND STATED THAT A DOCTOR HAD QUESTIONED THE IPTH RESULTS AND STATED THAT UNNECESSARY SURGERY HAD BEEN PERFORMED DUE TO ALLEGED DISCORDANT IPTH RESULTS OUTSIDE OF THE CUSTOMER'S EXPECTED RANGE OF 14-72 PG/ML. THE PATIENT'S SAMPLES WERE NOT REPEATED AND NOT SENT OUT FOR TESTING TO CONFIRM WHETHER OR NOT THEY WERE DISCORDANT. OTHER THAN THE ALLEGED UNNECESSARY SURGERY, THERE HAVE BEEN NO REPORTS OF IMPACT TO THE PATIENT OR ADVERSE HEALTH CONSEQUENCES DUE TO ALLEGED IPTH DISCORDANT RESULTS. SIEMENS HAS CONTINUED TO FOLLOW UP WITH THE CUSTOMER AND REQUESTED ADDITIONAL INFORMATION REGARDING THE ALLEGED SURGERY. THE CUSTOMER ONLY KNOWS THAT SURGERY DECISIONS WERE MADE BASED ON THE DATA AND NOT AWARE OF ANY COMPLICATIONS OR ADVERSE EVENTS DUE TO SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO SIEMENS AND THE CUSTOMER DECLINES FURTHER FOLLOW UP ON THE ISSUE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038843 ↗
• 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 ↗
• MalfunctionSep 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT HIGH ADVIA CENTAUR XP IPTH RESULT WAS OBTAINED FOR SAMPLES FROM SEVERAL PATIENTS DURING A COMPARISON STUDY. THE COMPARISON STUDY WAS BETWEEN REAGENT LOT 368 ON THE ADVIA CENTAUR XP AND AN ALTERNATE METHOD. THE COMPARISON WAS PERFORMED AFTER THE CUSTOMER RECEIVED COMPLAINTS FROM DOCTORS ABOUT SHIFT UP IN RESULTS ON PATIENT SAMPLES. 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 6889853 ↗
• MalfunctionSep 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE LOW ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT WAS OBTAINED ON A DILUTION SAMPLE, AND CONSIDERED DISCORDANT COMPARED TO A HIGH NEAT RESULT. THE CUSTOMER PERFORMED REPEAT IPTH TESTING, AND THE NEAT RESULT WAS HIGH COMPARED TO A LOWER DILUTION RESULT. THE SAME SAMPLE WAS RE-CENTRIFUGED, REPEAT IPTH TESTING PERFORMED, AND THE RESULTS WERE SIMILAR. ANOTHER SAMPLE ALIQUOT FROM THE SAME PATIENT WAS TESTED, AND THE IPTH RESULTS WERE SIMILAR. THE HIGH IPTH RESULT WAS REPORTED TO THE PHYSICIAN, AND CONSIDERED TO BE THE CORRECT RESULT. THE REPORTED RESULT WAS NOT QUESTIONED BY THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP IPTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6870217 ↗
• MalfunctionSep 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT ADVIA CENTAUR XP IPTH RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS GREATER THAN 1900. THE SAMPLE WAS DILUTED AND A VALID RESULT COULD NOT BE OBTAINED. A NEW SAMPLE DRAW WAS OBTAINED BY THE CUSTOMER AND WAS NOT TESTED ON THE ADVIA CENTAUR XP. THE SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS LOW. THE DOCTOR WAS EXPECTING TO SEE SIMILAR RESULTS TO RECENT PATIENT HISTORY. 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 6865410 ↗
• MalfunctionSep 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT ADVIA CENTAUR XP IPTH RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS GREATER THAN 1900. THE SAMPLE WAS DILUTED AND A VALID RESULT COULD NOT BE OBTAINED. THE PATIENT SAMPLE WAS REPEATED ON ANOTHER ADVIA CENTAUR XP AND THE RESULT WAS GREATER THAN 1900. THE SAMPLE WAS DILUTED AND A VALID RESULT COULD NOT BE OBTAINED. THE DOCTOR WAS EXPECTING TO SEE SIMILAR RESULTS TO RECENT PATIENT HISTORY. 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 6865377 ↗

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