ADVIA Centaur® iPTH 10492368Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00630414579153), received between Jul 18, 2017 and May 24, 2018 — classified as 5 injuries, 18 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, 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 23 most recent of 23 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 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 6865374 ↗
• 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 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 6865361 ↗
• MalfunctionAug 14, 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 (1:2) AND THE RESULT WAS LOW. THE PATIENT SAMPLE WAS DILUTED 1:5 AND 1:10. AN ERROR WAS OBTAINED. THERE WAS NO RESULT REPORTED FOR THIS PATIENT SAMPLE. 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 6791764 ↗
• MalfunctionAug 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 HIGH AND WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT. 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 6791760 ↗
• MalfunctionAug 14, 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 THAN1900. THE SAMPLE WAS DILUTED AND THE RESULT WAS LOW. THE RESULT WAS REPORTED AS "THAT THE IPTH RESULT WAS QUESTIONABLE WITH A POSSIBLE INTERFERING SUBSTANCE." 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 6791759 ↗
• MalfunctionAug 10, 2017Adverse 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, AND CONSIDERED DISCORDANT COMPARED TO A LOWER ADVIA CENTAUR SYSTEM IPTH RESULT FROM A SISTER HOSPITAL. THE CUSTOMER INITIALLY OBSERVED A HIGH BIAS FOR LEVEL 3 QUALITY CONTROL (QC) EVEN THOUGH QC WAS WITHIN THE LABORATORY'S ESTABLISHED RANGE. THERE WAS NO QC IMPROVEMENT WITH A NEW IPTH REAGENT LOT (056368), AND THE FALSE HIGH IPTH RESULT WAS OBSERVED WHEN PERFORMING A PATIENT RESULT COMPARISON WITH THE SISTER HOSPITAL. PER THE LABORATORY DIRECTOR, PATIENT RESULTS GREATER THAN 73 PG/ML WILL BE HELD FOR VERIFICATION TESTING. 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 6786236 ↗
• MalfunctionAug 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE LOW ADVIA CENTAUR XP IPTH RESULT WAS OBTAINED FOR A PATIENT SAMPLE DURING A LOT TO LOT CORRELATION. THE CORRELATION WAS BETWEEN REAGENT LOT 366 AND 368. LOT 368 WAS READING LOWER THAN LOT 366. THE PATIENT RESULT FROM LOT 368 WAS NOT REPORTED. 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 6762154 ↗
• MalfunctionJul 31, 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 OBSERVED BY THE CUSTOMER ON A PATIENT (BABY), AND CONFIRMED LOW WITH AN ALTERNATE IPTH TEST METHOD. THE LOW IPTH RESULT WAS QUESTIONED BY THE PHYSICIAN, THE PATIENT WAS REDRAWN, AND THE IPTH RESULT WHEN RUN ON ANOTHER ADVIA CENTAUR SYSTEM WAS NORMAL. A CORRECTED REPORT WAS ISSUED. 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 6755774 ↗
• MalfunctionJul 31, 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 OBSERVED BY THE CUSTOMER ON A PATIENT (BABY), AND CONFIRMED LOW WITH AN ALTERNATE IPTH TEST METHOD. THE LOW IPTH RESULT WAS QUESTIONED BY THE PHYSICIAN, THE PATIENT WAS REDRAWN, AND THE IPTH RESULT WHEN RUN ON ANOTHER ADVIA CENTAUR SYSTEM WAS NORMAL. A CORRECTED REPORT WAS ISSUED. 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 6755769 ↗
• MalfunctionJul 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER OBSERVED A LOWER THAN EXPECTED ADVIA CENTAUR CP INTACT PARATHYROID HORMONE (IPTH) RESULT. UPON REPEAT TESTING, THE RESULT WAS HIGHER. THIS WAS AN INTRAOPERATIVE IPTH TEST RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR CP IPTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6720604 ↗