MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATTELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA); CEA IMMUNOASSAY

Catalog Number	10995523
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant atellica im cea result is unknown.Siemens healthcare diagnostics is investigating.The instruction for use (ifu) in the interpretation of results section states: "warning do not use the atellica im cea assay 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 instruction for use (ifu) in the expected values section states: "as with all in vitro diagnostic assays, each laboratory should determine its own reference interval for the diagnostic evaluation of patient results.14 consider these values as guidance only.".
Event or Problem Description
A customer obtained a discordant cea result on the atellica im 1300 analyzer.The initial result was reported to the physician, who did not question the result.The customer indicated that quality control (qc) was found to be outside of the laboratory's acceptable range on 9/17/2019 on one atellica im 1300 analyzer (im00745).Qc was repeated and when confirmed to be in range cea samples were repeated on the same instrument.Discordance was found between the initial result and repeat result on one of these samples.The discordant sample was repeated again on a different atellica im 1300 analyzer (im00746) and result was similar to the first repeat result.Patient treatment was not prescribed or altered and there was no report of adverse health consequences due to the discordant cea result.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2019-00204 on october 10, 2019.Additional information from 11/22/2019: cea is a direct assay and an incorrect high result would be due to an increase in rlu's.Service was performed for the instrument however the reagent probes 1 and 2 were replaced which would not correct high rlu on a direct assay.Cea does not use reagent probe 2.Possible causes of gaining rlu for a direct assay the specifics can be found in cb docs.Issues with wash or aspiration, base delivery (dripping in luminometer), system contamination - this assay uses water for wash/rinse.Review of the data did not reveal a potential product problem.On a follow up visit the customer stated that they are operational and no further investigation is required.Based on the investigation, no product problem was identified.No further evaluation of the device is required.

• Brand Name: ATTELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA)
• Common Device Name: CEA IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9176997
• Report Number: 1219913-2019-00204
• Device Sequence Number: 2693002
• Product Code: DHX
• UDI-Device Identifier: 00630414598505
• UDI-Public: 00630414598505
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K981478
• 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
• Report Date (Section B): 01/06/2020

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: 02/06/2020
• Device Catalogue Number: 10995523
• Device Lot Number: 47916186
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1