ELECSYS CEA ASSAY

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CEA ASSAY, AND SEVERAL OTHER ASSAY RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS 6000 E601 (UL) V, WITH SERIAL NUMBER (B)(4). THE REPORTER STATED, THAT THE QC WAS OUT OF RANGE AND MULTIPLE PATIENT RESULTS WERE FLAGGED. THE REPORTER THEN RAN AN ASSAY PROFILE OF THE EVENING SHIFT AND NOTED, THAT THE QC FOR CEA WAS OUT OF RANGE TWICE. THE PROCELL AND CLEANCELL WERE THEN REPLACED. THE QC WAS RERUN WITH ACCEPTABLE RESULTS. THE REPORTER PULLED AN INTERFACE REPORT AND NOTICED SEVERAL LOW RESULTS ON MULTIPLE ASSAYS. THE REPORTER WAS ABLE TO PROVIDE TWO EXAMPLES OF QUESTIONABLE RESULTS. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. SAMPLE 1: ON (B)(6) 2023, THE INITIAL RESULT USING AN ALIQUOTED SAMPLE WAS 63.46 NG/ML. ON (B)(6) 2023, THE REPEAT RESULT USING THE PRIMARY TUBE (AFTER SERVICE) WAS 118.9 NG/ML. SAMPLE 2: THE INITIAL RESULT WAS 0.5 NG/ML. THE REPEAT RESULT WAS 5.66 NG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER INSPECTED THE MODULE AND COULD NOT FIND THE CAUSE OF THE EVENT. HE TIGHTENED THE SIPPER PROBES. AND THE CUSTOMER USED THE MODULE WITHOUT ANY ISSUES. THE LAST CALIBRATION PERFORMED ON 31-MAR-2023 WAS WITHIN SPECIFICATIONS. QC 1 WAS ACCEPTABLE ON THE DATE OF THE EVENT AND AFTER THE REPEAT. QC 3 HAD SOME OUT-OF-RANGE (HIGH) RESULTS. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE ALARM TRACE CONTAINED MULTIPLE "ABNORMAL ASPIRATION" ALARMS. THIS CAN BE AN INDICATOR OF POOR SAMPLE QUALITY. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.