PHOS2

Additional Manufacturer Narrative

SECTION D, DEVICE IDENTIFICATION WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE C702 MODULE SERIAL NUMBER WAS (B)(6). CALIBRATION AND QC WERE ACCEPTABLE. THE FIELD SERVICE ENGINEER (FSE) PERFORMED A COMPLETE INSTRUMENT CHECK AND NO ISSUES WERE IDENTIFIED. THE CUSTOMER HAS HAD NO FURTHER ISSUES. A GENERAL REAGENT ISSUE IS UNLIKELY AS CALIBRATION AND QC WERE ACCEPTABLE. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, THE QUESTIONABLE RESULT RECEIVED (0.00 MG/DL) SUGGESTS THE EVENT WAS CONSISTENT WITH A PRE-ANALYTIC ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE PHOS2 REAGENT LOT NUMBER WAS 82370701 WITH AN EXPIRATION DATE OF 31-DEC-2025.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR PHOSPHORUS (PHOS2) ON A COBAS 8000 C 702 MODULE. THE INITIAL RESULT WAS 0.00 MG/DL. THE OPERATOR REQUESTED REPEAT TESTING. THE REPEAT RESULT WAS 3.79 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.