PHOS2 PHOSPHATE (INORGANIC) VER.2

Additional Manufacturer Narrative

UNIQUE IDENTIFIER (UDI) # (B)(4). THE CUSTOMER FOUND A DEFECTIVE REAGENT PACK AND THAT THE PROBE TIP WAS BLOCKED WITH PLASTIC. THE PROBE WAS REPLACED. PRECISION STUDIES WERE PERFORMED AND WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF A QUESTIONABLE PHOS GEN.2, RESULT FOR 1 PATIENT SAMPLE, ON A COBAS 6000 C (501) MODULE ANALYZER SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 1.9 MG/DL AND THE REPEAT RESULT WAS 3.4 MG/DL. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY.

Additional Manufacturer Narrative

IT WAS PREVIOUSLY STATED THE CUSTOMER FOUND "THAT THE PROBE TIP WAS BLOCKED WITH PLASTIC. THE PROBE WAS REPLACED. PRECISION STUDIES WERE PERFORMED AND WERE ACCEPTABLE." THIS WAS CORRECTED TO HAVING BEEN FOUND BY THE FIELD SERVICE ENGINEER. THE LAST CALIBRATION WAS PERFORMED ON (B)(6) 2020 WITH ACCEPTABLE RESULTS. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT. THE INVESTIGATION DETERMINED THAT THE ISSUE FOUND BY THE FIELD SERVICE ENGINEER WAS THE ROOT CAUSE OF THE EVENT.