inforMED
MalfunctionDHX

ADVIA CENTAUR XP CEA ASSAY

Received Oct 4, 2016 · Event occurred Sep 20, 2016

Report 1219913-2016-00180 · MDR key 5997516

Device

Generic name

Cea Immunoassay

Model number

N/A

Catalog number

10309977

Lot number

164

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2016-00180 ON 10/04/2016 FOR A FALSELY ELEVATED ADVIA CENTAUR XP CARCINOEMBRYONIC ANTIGEN (CEA) RESULT OBTAINED ON A PATIENT SAMPLE. ON 10/21/2016 - ADDITIONAL INFORMATION: A SIEMENS SERVICE REPRESENTATIVE TESTED THE PATIENT SAMPLE ON AN ADVIA CENTAUR SYSTEM AND IMMULITE SYSTEM FOR CARCINOEMBRYONIC ANTIGEN (CEA) AT AN ALTERNATE LABORATORY. THE PATIENT SAMPLE WAS RUN NEAT, AND RUN TREATED WITH A HETEROPHILIC BLOCKING TUBE (HBT). IT WAS OBSERVED THAT THE HBT ADVIA CENTAUR SYSTEM CEA RESULTS WERE DECREASED, INDICATING HETEROPHILIC INTERFERENCE. CEA TEST RESULTS: ADVIA CENTAUR SYSTEM RESULTS: IMMULITE SYSTEM RESULTS: NEAT (UNTREATED), 40.26 NG/ML, 28.89 NG/ML, 2.16 NG/ML, 2.16 NG/ML. HBT (TREATED), 2.31 NG/ML, 2.65 NG/ML, 2.1 NG/ML, 1.93 NG/ML. THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATION NOTE SECTION STATES THE FOLLOWING: "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." "HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS. PATIENTS ROUTINELY EXPOSED TO ANIMALS OR TO ANIMAL SERUM PRODUCTS CAN BE PRONE TO THIS INTERFERENCE AND ANOMALOUS VALUES MAY BE OBSERVED. ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER INVESTIGATION IS REQUIRED.

Additional Manufacturer Narrative

THE CAUSE FOR THE FALSELY ELEVATED ADVIA CENTAUR XP CEA RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING. THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATION NOTE SECTION STATES THE FOLLOWING: "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."

Description of Event or Problem

A FALSELY ELEVATED ADVIA CENTAUR XP CARCINOEMBRYONIC ANTIGEN (CEA) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE CUSTOMER PERFORMED REPEAT TESTING AND THE RESULTS WERE ELEVATED. THE ELEVATED ADVIA CENTAUR XP RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO PREVIOUS PATIENT RESULTS. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE CEA TEST METHOD AND THE RESULTS WERE LOWER. THE INITIAL ADVIA CENTAUR XP CEA RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP CEA RESULT.