ELECSYS CA 19-9

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CA 19-9 AND ELECSYS CEA RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS 6000 E601 MODULE. THIS MEDWATCH IS FOR THE ELECSYS CA 19-9 ASSAY. PLEASE REFER TO MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS CEA ASSAY. ON (B)(6) 2024: THE INITIAL RESULT FROM THE REPORTED REAGENT LOT WAS 459.90 U/ML. THE FIRST REPEAT RESULT FROM A DIFFERENT ELECSYS CA19-9 REAGENT PRODUCT WAS 28.82 U/ML. ON (B)(6) 2024: THE SECOND REPEAT RESULT FROM A NEW REAGENT PACK OF THE SAME REPORTED REAGENT LOT WAS 26.52 U/ML.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE COBAS 6000 E601 MODULE IS (B)(6). THE CUSTOMER DOES NOT USE THE REQUIRED TIP/CUP FOR THE MODULE. THE MEASURING CELLS WERE OVERDUE FOR REPLACEMENT. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ISSUE WAS CONSISTENT WITH THE CUSTOMER'S USE OF UNAPPROVED PROCELL, CLEANCELL, AND TIP/CUPS. A GENERAL REAGENT PROBLEM WAS NOT PRESENT, BECAUSE THE QC BEFORE THE EVENT WAS WITHIN RANGES.