MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY; IPTH IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant ipth result is unknown.Siemens healthcare diagnostics is investigating.The limitations section of the instructions for use states: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.Interpretation of intact pth values should always take into account serum calcium results and the interrelationship between these two elements in various disorders involving pth and calcium.It is recommended that the intact pth results should always be interpreted with caution and with consideration of the overall clinical manifestations even when used in conjunction with calcium values." mdr 1219913-2018-00133 was filed for the same event.
Event or Problem Description
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.
Additional Manufacturer Narrative
04/20/2018 additional information: the customer's calibration and control data does not indicate an issue that would elevate sample recovery.The patient sample was not evaluated to see if there is an interferent present.The customer is unable to provide any medical history for the patients or the calcium values for the patient samples.With the information provided there is no way to determine if the advia centaur xp ipth value is elevated or the alternate method ipth value is depressed.There is no sample available to evaluate.Siemens makes no claims regarding how the advia centaur xp ipth assay recovers when compared to the alternate method ipth assay.The ifu states in the limitation section: "the advia centaur ipth assay will detect non-intact pth (1-84) such as pth fragment (7-84).Pth fragment (7-84) may cause falsely elevated ipth results in patients with abnormal renal function because these patients may have various concentrations of pth fragment (7-84) in their blood.In patients with abnormal renal function, interpret the ipth result with caution, and do not make patient management decisions on the ipth result alone.A study of characterized pth fragments is provided in lopez et al (selected reaction monitoring-mass spectrometric immunoassay responsive to parathyroid hormone and related variants)." the cause for the discordant ipth results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2018-00133 supplemental report 1 was filed for the same event.

• Brand Name: ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY
• Common Device Name: IPTH IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7404713
• Report Number: 1219913-2018-00128
• Device Sequence Number: 35791
• Product Code: CEW
• UDI-Device Identifier: 00630414579153
• UDI-Public: 00630414579153
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K133601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2018
• Device Model Number: N/A
• Device Catalogue Number: 10492368
• Device Lot Number: 97621369
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR