PHOS2

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH PHOS2 PHOSPHATE (INORGANIC) VER.2 ON A COBAS 6000 C (501) MODULE (SERIAL NUMBER (B)(4) ). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A PHOSPHATE VALUE OF 1.0 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 3.2 MG/DL AND THIS VALUE WAS DEEMED CORRECT AND REPORTED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

THE CALIBRATION PERFORMED ON 29-JAN-2023 WAS OK AND THERE WERE NO ALARMS. THE SAME REAGENT PACK WAS CALIBRATED ON 30-JAN-2023 AND THERE WERE VARIATIONS IN THE CALIBRATION SIGNALS. ONE LEVEL OF QUALITY CONTROL SHIFTED OUTSIDE OF RANGE ON 29-JAN-2023 AND A SECOND LEVEL OF CONTROL SHIFTED OUTSIDE OF RANGE ON 30-JAN-2023. THE FIELD SERVICE ENGINEER CHECKED THE SYSTEM AND COULD NOT FIND ANYTHING WRONG. THE CUSTOMER REPLACED THE REAGENT AND NO ISSUES WERE OBSERVED. THE CUSTOMER BELIEVES THE REAGENT "STAYED OUT FOR A WHILE". THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.