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	11/21/2017
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.".
Event or Problem Description
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.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2017-00238 on december 11, 2017.12/21/2017 additional information: the patient sample was not available for in house testing due to sample volume.Siemens is unable to determine potential cause.Siemens cannot rule out an un-identified interference as the potential cause for the falsely depressed ipth value.Additional interference testing could not be completed due to insufficient sample volume.The cause for the discordant ipth results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

• 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: 7106888
• Report Number: 1219913-2017-00238
• Device Sequence Number: 1461283
• Product Code: CEW
• UDI-Device Identifier: 00630414579160
• UDI-Public: 00630414579160
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2018

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: 10/18/2018
• Device Model Number: N/A
• Device Catalogue Number: 10492369
• Device Lot Number: 09297370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1