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	09/12/2018
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.".
Event or Problem Description
Discordant results were obtained for a patient between serum and plasma samples on the advia centaur xp intact parathyroid hormone (pth) assay during a correlation study between laboratories.The serum sample result was lower than the plasma result.A physician noticed the difference in results during the study.Patient treatment was not 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 1219913-2018-00242 on october 05, 2018.11/06/2018 additional information: the site tas (technical application specialist) was requested to perform a six patient correlation study from the customer's advia centaur to another site.One of the customer clients wanted the study to be done.The samples used for the study were plasma.The details of the study were not provided as the customer is waiting for more patient samples or waiting for direction from their medical director.The customer has the tas performing a study with a sister laboratory that is using advia centaurs and is using the same reagent and calibrator lot.The customer is awaiting 2 more samples for the study.Siemens continues to contact the customer to provide the results of the correlation study.Siemens healthcare diagnostics is awaiting further information.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2018-00242 on october 05, 2018.Siemens filed the mdr 1219913-2018-00242 supplemental report 1 on november 28, 2018.12/04/2018 additional information: the customer has not provided samples for the study for an extended period of time and the site tas (technical application specialist) has closed the task.The customer indicated they would repeat the correlation study using the same sample type.However, the correlation study has not been performed due to the lack of samples.Siemens has been waiting for the data for several months.Siemens cannot determine the root cause for the discordant sample observed.A new notification will be opened if customer wants to perform any other sample studies.The customer reports the pth quality control is performing in range and the pth assay has been performing within specifications.The instrument is performing within specifications.No further evaluation of the device is required.

• 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: 7938022
• Report Number: 1219913-2018-00242
• Device Sequence Number: 770059
• Product Code: CEW
• UDI-Device Identifier: 00630414592343
• UDI-Public: 00630414592343
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 12/26/2018

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: 06/27/2019
• Device Model Number: N/A
• Device Catalogue Number: 10699155
• Device Lot Number: 39951015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 11/06/2018; 12/04/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/28/2018; 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1