MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CEA ASSAY; CEA 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	11/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer observed floating fibrin in serum of the patient sample.The advia centaur xp cea ifu (10629830_en rev.M, 2019-02) states to make sure "samples are free of fibrin or other particulate matter.Remove particulates by centrifugation at 1000 x g for 15-20 minutes." pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.Siemens cannot rule out pre-analytical factors such as fibrin being present in the sample as the cause for the non-reproducible results.Based on the information provided, no product problem identified.The instrument is performing within specifications.No further evaluation of the device is required.The instruction for use (ifu) in the interpretation of results section states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instruction for use (ifu) in the limitations section states: "warning do not use the advia centaur cea immunoassay as a screening test for diagnosis.Note: do not interpret levels of cea as absolute evidence of the presence or the absence of malignant disease.Measurements of cea should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.The concentration of cea in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity.Cea determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity.".
Event or Problem Description
A falsely elevated advia centaur xp cea result was obtained for a patient sample.The elevated result was reported to the clinician and was questioned.The laboratory queried the past results and were all negative.The patient sample was repeated on another advia centaur xp and the result was negative.The patient sample was repeated on the initial advia centaur xp and the result was negative.A corrected report was issued.Patient treatment was not altered or prescribed.There was no report of adverse health consequences due to the discordant advia centaur xp cea results.

• Brand Name: ADVIA CENTAUR XP CEA ASSAY
• Common Device Name: CEA IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9511030
• Report Number: 1219913-2019-00280
• Device Sequence Number: 2217117
• Product Code: DHX
• UDI-Device Identifier: 00630414177304
• UDI-Public: 00630414177304
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K981478
• 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
• Report Date (Section B): 12/23/2019

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: 06/14/2020
• Device Model Number: N/A
• Device Catalogue Number: 10309977
• Device Lot Number: 02493189
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR