MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) ASSAY; PTH 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	03/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient sample is not available for further testing and investigation.The sample type was edta.The customer indicated the physician expected a lower result.Without the sample and the requested information, siemens is unable to determine the cause of the falsely elevated result.Siemens cannot rule out sample specific issue most likely due to some unidentified interference as the potential root cause for the discordant result.The cause for the discordant ipth result is unknown.The instrument is performing within specifications.No further evaluation of the device is required.The interpretation of results of the instructions for use states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the limitations section of the instructions for use states: "interpretation of intact pth values should always take into account serum calcium results and the interrelationship between these 2 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 1219913-2018-00131 was filed for the same event.
Event or Problem Description
A discordant elevated result was obtained for a patient sample on the advia centaur xp intact parathyroid hormone (pth) assay.The result was questioned by the phycisian.The result was higher than expected, the sample was repeated three times on a later date and the results were elevated.A redraw patient sample was tested on an alternate method at a different location 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 pth result.

• Brand Name: ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) ASSAY
• Common Device Name: PTH IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7432973
• Report Number: 1219913-2018-00132
• Device Sequence Number: 1094446
• Product Code: CEW
• UDI-Device Identifier: 00630414592336
• UDI-Public: 00630414592336
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K163658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2018

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: 08/23/2018
• Device Model Number: N/A
• Device Catalogue Number: 10699154
• Device Lot Number: 25427004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1