ADVIA CENTAUR XP CEA ASSAY

Additional Manufacturer Narrative

THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CEA RESULT IS UNKNOWN. POSSIBLE UNIDENTIFIED INTERFERRANT. THE QUALITY CONTROL AND CALIBRATION WERE ACCEPTABLE. THE PREVENTIVE MAINTENANCE (PM) AND MAINTENANCE WERE DONE ON THE INSTRUMENT. NO ISSUES IDENTIFIED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION FO THE DEVICE IS REQUIRED. THE INSTRUCTION FOR USE (IFU) LIMITATION SECTION STATES: "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. 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."

Description of Event or Problem

LOW ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED ON TWO DIFFERENT ALTERNATE METHODS AND THE RESULTS WERE HIGHER. THE PREVIOUS RESULT FOR THE PATIENT WAS LOW ON THE ADVIA CENTAUR XP. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CEA RESULT.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2015-00153 ON OCTOBER 8, 2015. ON 04/07/2016 ADDITIONAL INFORMATION: THE CUSTOMER SENT IN THE PATIENT SAMPLE FOR FURTHER TESTING AND INVESTIGATION. THE PATIENT SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP, THE IMMULITE 2000, AND THE DIMENSION VISTA PLATFORMS. SID (B)(6) RESULTS: ADVIA CENTAUR XP: 3.55 AND 3.42 NG/ML, IMMULITE 2000: 15.2 AND 14.7 NG/ML, DIMENSION VISTA: 4.1 NG/ML. BASED ON THE ABOVE CEA RESULTS, IT APPEARS THAT THERE MAY BE SOMETHING IN THE PATIENT SAMPLE THAT IS INTERFERING WITH THE TWO ALTERNATE METHOD ASSAYS AS THE RESULTS WERE HIGHER (38 AND 44 NG/ML). SIEMENS IS CHECKING IF THERE IS ENOUGH VOLUME OF THE PATIENT SAMPLE TO BE TESTED FOR HBT (HETEROPHILIC BLOCKING TUBE).

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2015-00153 ON OCTOBER 8, 2015. SIEMENS FILED THE MDR 1219913-2015-00153 SUPPLEMENTAL REPORT 1 ON APRIL 21, 2016. ON 04/26/2016 ADDITIONAL INFORMATION: THE CUSTOMER SENT IN THE FOLLOWING RESULTS: RESULTS (NG/ML): (B)(6). ON 05/03/2016: THE PATIENT'S CLINICAL CONDITION WAS PROVIDED. THE PATIENT IS IN CONSULTATION. A SCAN WAS PERFORMED ON (B)(6) 2015 WHICH DID NOT SHOW SUSPECT LESION AND A DISAPPEARANCE OF THE SMALL NODULAR LESION SPICULE LINGUAL. TREATMENT: GAVISCON ACCORDING TO NEED REMERON 30 MG, ZALDIAR 2-3 X/ N (DORSAL PAINS), TRAMAL 100 MG 1 X GENERALLY THE NIGHT, PROSCAR, LIBRAX 2 X 100 MG MOTILIUM, TEMESTA IN RESERVE. MALE - (B)(6). HISTORIC: GASTRIC DIFFUSE ADENOCARCINOMA ((B)(6) 2009). TOTAL GASTROSTOMY, POCKET JEJUNA ((B)(6) 2009). DAP: STADIUM PT1PN0 (0/11) M0. CHRONIC HYPOTHERMIA UNDETERMINED ETIOLOGY. CRISIS COMITIALE, EPILEPTOGENIC NEGATIVE RESULTS. OTHER TESTING AND RESULTS: CA19-9 NORMAL 15.21 (NSE IN (B)(6) 2015 CLOSE TO HIGH NORMAL VALUE) THE PATIENT SAMPLE WILL BE SHIPPED TO SIEMENS FOR HBT (HETEROPHILIC BLOCKING TUBE) TESTING IN-HOUSE.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2015-00153 ON OCTOBER 8, 2015. SIEMENS FILED THE MDR 1219913-2015-00153 SUPPLEMENTAL REPORT 1 ON APRIL 21, 2016. SIEMENS FILED THE MDR 1219913-2015-00153 SUPPLEMENTAL REPORT 2 ON MAY 12, 2016. ON 6/17/2016 ADDITIONAL INFORMATION: THE PATIENT SAMPLE WAS NOT SHIPPED TO SIEMENS FOR ADDITIONAL HBT (HETEROPHILIC BLOCKING TUBE) TESTING IN-HOUSE. THE HBT TESTING WAS ALREADY PERFORMED BY THE CUSTOMER/ REGION. THE PATIENT SAMPLE FROM THE PATIENT WAS TREATED WITH A HETEROPHILIC BLOCKING TUBE (HBT). HOWEVER, THE RESULTS DID NOT CHANGED SIGNIFICANTLY FOR THE ADVIA CENTAUR XP CEA ASSAY AND THE TWO CEA ALTERNATE METHOD ASSAYS. THE ALTERNATE METHOD ASSAYS MAY USE THE SAME OR SIMILAR ANTIBODIES. THE REGION PROVIDED THAT THE ALTERNATE METHOD 2 USES TWO MOUSE MONOCLONAL ANTIBODIES. THE ADVIA CENTAUR XP CEA ASSAY USES A RABBIT POLYCLONAL AND A MOUSE MONOCLONAL WHICH SHOULD MAKE IT LESS SUSCEPTIBLE TO INTERFERENCE THAN AN ASSAY THAT USES TWO MONOCLONAL ANTIBODIES. THE ADVIA CENTAUR XP AND DIMENSION VISTA CEA ASSAYS DO NOT USE THE SAME ANTIBODIES. THE CHANCE THAT BOTH ASSAYS ARE MISSING A CEA EPITOPE IS VERY SLIM. THE ALTERNATE METHOD 2 CEA INSTRUCTIONS FOR USE (IFU) INDICATES THAT MECONIUM ANTIGEN (NCA2) INTERACTS WITH THE ANTIBODIES USED IN THEIR ASSAY. AS STATED IN THE IFUS FOR THE ADVIA CENTAUR XP AND THE DIMENSION VISTA CEA ASSAYS, NCA2 DOES NOT CROSS REACT WITH THESE ASSAYS. THE ALTERNATE METHOD 1 AND IMMULITE CEA IFUS DO NOT MENTION WHETHER NCA2 CROSS REACTS OR NOT. IT IS POSSIBLE THIS PATIENT SAMPLE CONTAINS NCA2 WHICH IS CROSS REACTING WITH THE TWO ALTERNATE METHOD ASSAYS AND TO A LESSER EXTENT WITH THE IMMULITE CEA ASSAY. UNFORTUNATELY THERE IS NO WAY TO TEST THIS THEORY. BASED ON THE INVESTIGATION AND THE DATA PROVIDED BY THE CUSTOMER, THERE IS PROBABLY SOMETHING IN THE SAMPLE THAT IS INTERFERING WITH THE ALTERNATE METHOD ASSAYS. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CEA RESULT IS UNKNOWN. POSSIBLE UNIDENTIFIED INTERFERRANT WITH THE ALTERNATE METHOD ASSAYS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION FO THE DEVICE IS REQUIRED. THE INSTRUCTION FOR USE (IFU) LIMITATION SECTION STATES: "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. 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."