inforMED
MalfunctionDHX

ADVIA CENTAUR XPT CARCINOEMBRYONIC ANTIGEN ASSAY

Received Aug 3, 2017 · Event occurred Nov 7, 2016

Report 1219913-2017-00167 · MDR key 6765408

Device

Generic name

Cea Immunoassay,

Model number

N/A

Catalog number

10309977

Lot number

040168

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 1219913-2017-00167 ON 08/03/2017 FOR A FALSE LOW ADVIA CENTAUR XPT CARCINOEMBRYONIC ANTIGEN (CEA) PATIENT RESULT. 08/11/17 - ADDITIONAL INFORMATION: THE CAUSE FOR FALSE LOW ADVIA CENTAUR XPT CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS COMPARED TO HIGHER CEA RESULTS WHEN TESTED ON AN ALTERNATE TEST METHOD AT ANOTHER HOSPITAL IS UNKNOWN. THE PATIENT SAMPLE IS NOT AVAILABLE FOR TESTING BY SIEMENS. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) 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) LIMITATION 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." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Additional Manufacturer Narrative

THE CAUSE FOR THE FALSE LOW ADVIA CENTAUR XPT RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING. THE INSTRUCTION FOR USE (IFU) 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) LIMITATION 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. WARNING: DO NOT USE THE ADVIA CENTAUR CEA IMMUNOASSAY AS A SCREENING TEST FOR DIAGNOSIS."

Description of Event or Problem

FALSE LOW ADVIA CENTAUR XPT CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS WERE OBTAINED ON A PATIENT AND CONSIDERED DISCORDANT COMPARED TO HIGHER CEA RESULTS WHEN TESTED ON AN ALTERNATE TEST METHOD AT ANOTHER HOSPITAL. THE PHYSICIAN QUESTIONED THE LOWER ADVIA CENTAUR XPT CEA RESULTS AS THEY DO NOT REFLECT THE PATIENT'S CLINICAL HISTORY. THE LABORATORY REPORTED BOTH THE ADVIA CENTAUR XPT CEA RESULT, AND THE ALTERNATE CEA TEST METHOD RESULT TO THE PHYSICIAN. THERE IS NO KNOWN REPORT THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT CEA RESULTS.