ADVIA CENTAUR CA 19-9

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF AN ELEVATED ADVIA CENTAUR CA 19-9 RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND REPEAT TESTING. MDR 1219913-2025-00023 WAS INITIALLY SUBMITTED ON 16-JAN-2025. UPDATE, 27-JAN-2025: SIEMENS HAS CONCLUDED THE INVESTIGATION. THE AFFECTED PATIENT HAS PANCREATIC CANCER, CHOLESTASIS, AND BILIARY OBSTRUCTION. THE CUSTOMER WAS NOT ABLE TO PROVIDE OR A LIST OF MEDICATIONS/SUPPLEMENTS THE PATIENT WAS TAKING. AN ISOLATED ELEVATED RESULT WAS OBTAINED IN REPEAT TESTING; THIS RESULT CONFLICTED WITH THE INITIAL TEST RESULT AND ALSO CONFLICTED WITH THE PATIENT¿S HISTORICAL TESTING. REPEAT-TESTING OF THE SAME SAMPLE IN ANOTHER LAB, USING ADVIA CENTAUR CA 19-9, LOT 541, PRODUCED A LOW RESULT. RETURN OF THE PATIENT SAMPLE WAS NOT WARRANTED, AS THE DISCORDANCE WAS NOT REPRODUCIBLE. REAGENT ISSUES WERE ESSENTIALLY RULED OUT, AS REVIEW OF CUSTOMER CALIBRATION AND QUALITY CONTROL (QC) DATA REVEALED NO ISSUES, AND NO PROBLEMS WERE REPORTED FOR ANY OTHER SAMPLES. THE INSTRUMENT WAS EVALUATED BY SERVICE AND NO ISSUES WERE FOUND. PROVIDED INFORMATION INDICATES THAT THE SAMPLE WAS HANDLED ACCORDING TO THE INSTRUCTIONS OF THE TUBE MANUFACTURER. HOWEVER, THE OBSERVATION THAT THE SAMPLE WAS HIGHLY JAUNDICED (ICTERIC) MAY INDICATE THAT SAMPLE QUALITY ISSUES PLAYED A ROLE IN THE REPORTED OBSERVATION. BASED ON THE AVAILABLE INFORMATION, A SPECIFIC CAUSE FOR THE DISCORDANT RESULT COULD NOT BE DETERMINED. NO PRODUCT PROBLEM WAS IDENTIFIED, AND THE ISSUE WAS RESOLVED WITH ROUTINE TROUBLESHOOTING. NO FURTHER INVESTIGATION IS REQUIRED. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR CA 19-9 RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND REPEAT TESTING WHEN USING CA 19-9 LOT: 543. AN INITIAL LOW CA 19-9 RESULT WAS OBTAINED FOR A FEMALE PANCREATIC CANCER PATIENT. WHEN THE SAMPLE WAS RE-TESTED, A MUCH HIGHER RESULT WAS PRODUCED; THIS ELEVATED RESULT WAS IDENTIFIED AS DISCORDANT. THE SAME SAMPLE WAS SENT TO AN EXTERNAL REFERENCE LABORATORY FOR TESTING, USING ADVIA CENTAUR CA 19-9, LOT: 541. THE REFERENCE-LAB RESULT (BELOW ASSAY CUTOFF) WAS CONSISTENT WITH EXPECTATION AND PATIENT HISTORY. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR ANY OTHER ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF AN ELEVATED ADVIA CENTAUR CA 19-9 RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND REPEAT TESTING WHEN USING CA 19-9 LOT: 543. NO ISSUES WERE IDENTIFIED WITH ASSAY CALIBRATION OR QUALITY CONTROL (QC) RESULTS. THE CA 19-9 ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." SIEMENS IS EVALUATING.