MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP 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	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens field service engineer (fse) was sent to the customer site.Quality control (qc) has been running normally.The fse checked probe alignments, tubing and pumps for leaks, and wash separator blocks.No issues found.The fse checked, cleaned and dried the lumonometer.The customer ran qc and the results were in range.The fse observed that the samples in question did not have the cell separator filter in place as they normally would.The customer explained that there is a filter that gets pushed into the tube.They make sure not to push too far, or they will get cells in thru the filter also.The filter stays in between the cells and plasma.The whole primary tube was placed on the analyzer for testing with the filter in it.The edta tubes don't come with cell separators or have gel separators.The cause for the discordant pth result is unknown.The customer routinely uses a filter in the edta tubes and this time they did not for those samples.Preanalytical factors cannot be ruled out.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 1219913-2019-00002 (first patient, 2nd sample) and mdr 1219913-2019-00003 (second patient) were filed for the same event.
Event or Problem Description
A discordant elevated result was obtained for a patient sample on the advia centaur cp intact parathyroid hormone (pth) assay.The result was questioned by the physician.The result was higher than expected.The sample was repeated and the result was lower.A corrected report was issued.The same patient had a sample drawn on december 22nd.The sample was tested and the result was elevated.The result was questioned by the physician.The result was higher than expected.The sample was repeated and the result was lower.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.

• Brand Name: ADVIA CENTAUR CP 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: 8238396
• Report Number: 1219913-2019-00001
• Device Sequence Number: 13991919
• Product Code: CEW
• UDI-Device Identifier: 00630414592336
• UDI-Public: 00630414592336
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 01/10/2019

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: 10/02/2019
• Device Model Number: N/A
• Device Catalogue Number: 10699154
• Device Lot Number: 76085019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2018
• Initial Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1