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	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration and quality control (qc) results were checked and were acceptable.The cause for the discordant cea results is unknown.Siemens healthcare diagnostics is investigating.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." mdr 1219913-2020-00123 (sample 1, (b)(6) 2020), 1219913-2020-00124 (sid (b)(6), (b)(6) 2020), and 1219913-2020-00125 (sid (b)(6), (b)(6) 2020) were filed for the same event.
Event or Problem Description
Falsely low advia centaur xp cea results were obtained for a patient sample with reagent lot 189.The patient sample was tested on two alternate methods and the results were higher.A second sample was tested on the advia centaur xp and the cea results were low with reagent lot 189.The second sample was also tested on the two alternate methods and the results were higher.The second patient sample was repeated on reagent lot 193 on the advia centaur xp.The result obtained was similar to the result from lot 189.The discordant results were reported and questioned by the physician.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.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2020-00126 on (b)(6), 2020.(b)(6), 2020 additional information: advia centaur xp cea lots 040189 and 040193 multiple samples from same patient are discordant compared to alternate methods.The advia centaur xp cea ifu (10629830_en rev.N, 2020-04) states "the concentration of cea in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the cea assay used.Values obtained with different assay methods cannot be used interchangeably.If, in the course of monitoring a patient, the assay method used for determining serial cea levels is changed, the laboratory must perform additional serial testing to confirm baseline values." the upper limit of normal for the advia centaur cea assay is 5.0 ng/ml.Both samples with both lots resulted higher than 5.0 ng/ml.The alternate methods results for these samples were also higher than their normal range.The assay is performing as expected.Based on the information provided, no product problem identified.The instrument is performing within specifications.No further evaluation of the device is required.Section h6, the device, method, results and conclusion codes were updated to reflect the additional information.Mdr 1219913-2020-00123 supplemental report 1, 1219913-2020-00124 supplemental report 1, and 1219913-2020-00125 supplemental report 1 were filed for the same event.

• Brand Name: ADVIA CENTAUR XP CEA ASSAY
• Common Device Name: CEA IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10067918
• Report Number: 1219913-2020-00126
• Device Sequence Number: 776898
• Product Code: DHX
• UDI-Device Identifier: 00630414177311
• UDI-Public: 00630414177311
• 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,Followup
• Report Date (Section B): 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2020
• Device Model Number: N/A
• Device Catalogue Number: 10309978
• Device Lot Number: 193
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 06/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR