MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM CARCINOEMRYOINIC (CEA); CEA IMMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics is investigating this event.The limitations section of the instructions for use states the following: "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.".
Event or Problem Description
A customer observed a discordant, elevated atellica im carcinoemryoinic (cea) result.The discordant result was not reported to the physician.The sample was retested twice and results were lower.One of the retest results was reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant cea result.
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr 1219913-2021-00051 initial report on (b)(6) 2021.Additional information - (b)(6) 2021: siemens has completed the investigation for an imprecisie (discordant, elevated) atellica im carcinoemryoinic (cea) patient result.Siemens reviewed the available information to determine probable root cause for the imprecision.Instrument sample and reagent aspirations were reviewed via instrument log files.Aspirations successfully completed and did not show any anomalies in the traces.No errors are shown in the icdebug log during processing of the sample.The available data does not indicate a hardware issue has caused the discordant results.According to the detection capability section of the atellica im cea instructions for use (ifu), "the loq corresponds to the lowest amount of carcinogenic antigen in a sample at which the within laboratory cv is
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr 1219913-2021-00051 initial report on 2021-01-11 and mdr 1219913-2021-00051 supplemental 1 report 2021-02-25.Correction - 2021-03-17: siemens' investigation for this event was previously completed as documented in mdr 1219913-2021-00051 supplemental 1 report.However, on 2020-03-17 a correction to the sample id was provided to siemens.The sample id initially reported for this event was sample id "(b)(6)", but the correct sample id for this event is "(b)(6)".

• Brand Name: ATELLICA IM CARCINOEMRYOINIC (CEA)
• Common Device Name: CEA IMMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11146363
• Report Number: 1219913-2021-00051
• Device Sequence Number: 3286159
• Product Code: DHX
• UDI-Device Identifier: 00630414598505
• UDI-Public: 00630414598505
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K981478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2021

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: 08/03/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995523
• Device Lot Number: 198
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 02/02/2021; 03/17/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/25/2021; 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR