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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics is investigating the cause for the discordant pth result.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 1219913-2019-00032 was filed for the same event.
Event or Problem Description
A discordant high advia centaur xp intact parathyroid hormone (pth) result was obtained for a patient sample.The sample was repeated and the result was high.A second sample from the same patient was tested and the result was lower.The second sample was repeated and the result was lower.Results from both samples were reported to the physician.The physician questioned the results.It is unknown if patient treatment was prescribed or altered.There was no report of adverse health consequences as a result of the discordant pth result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2019-00037 on march 15, 2019.03/19/2019 additional information: the quality control (qc) and calibration were valid.A list of medications was not provided for the patient.No clinical history provided.The ifu states in the collecting the specimen section: "for serum specimens, complete clot formation should take place before centrifugation.Serum should be physically separated from cells as soon as possible with a maximum limit of 2 hours from the time of collection." for edta samples no guidelines have been provided.For edta samples, siemens referred to clinical and laboratories standards institute gp-44-a4 procedure.Based on this clsi document, intact pth is stable for up to 24 hours un-centrifuged.Please note siemens performed their stability studies using centrifuged specimens only.Siemens cannot determine root cause.However, pre-analytical factors cannot be ruled out as the possible root cause of the discordant result.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00032 supplemental report 1 was filed for the same event.

• 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: 8424423
• Report Number: 1219913-2019-00037
• Device Sequence Number: 2227227
• Product Code: CEW
• UDI-Device Identifier: 00630414592343
• UDI-Public: 00630414592343
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 04/02/2019

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: 11/06/2019
• Device Model Number: N/A
• Device Catalogue Number: 10699155
• Device Lot Number: 94259020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1