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	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The quality control (qc) was in range.The first run result of 0.7 was ran on reagent pack id 01155 and repeated results were >212 ran on reagent pack id 01156.No other sample was reported as low for pth on this reagent pack and this sample was evaluated only for pth.The sample type was plasma.Siemens healthcare diagnostics is investigating.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
A discordant low advia centaur xp intact parathyroid hormone (pth) result was obtained for a patient sample.The result was reported to the physician and questioned.The physician was expecting a higher result.The sample was repeated twice and the results were higher.A corrected report was issued.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 on (b)(6) 2020.(b)(6), 2020 additional information: the customer reported a discordant intact parathyroid hormone (pth) patient sample on the advia centaur xp reagent lot 033.The initial result was 0.7 pmol/l.The doctor questioned the result as a higher value was expected.The patient had a prior pth value in 2015 of 153.4 pmol/l.The sample was repeated to obtain a result of 557.1 pmol/l.The sample was repeated once again to obtain the same result of 517.6 pmol/l.No other discordant samples were reported.The sample type was plasma.The calibration and quality control (qc) valid.Siemens cannot determine the root cause of the falsely low discordant patient sample; however, pre-analytical factors cannot be ruled out.Siemens reviewed in house data for kit lot 033.Siemens did not identify a product problem.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
• MDR Report Key: 9735188
• Report Number: 1219913-2020-00073
• Device Sequence Number: 3320359
• Product Code: CEW
• UDI-Device Identifier: 00630414592343
• UDI-Public: 00630414592343
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K163658
• 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): 03/09/2020

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: 07/09/2020
• Device Model Number: N/A
• Device Catalogue Number: 10699155
• Device Lot Number: 06552033
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1