PHOS2 PHOSPHATE (INORGANIC) VER.2

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THE CAUSE TO BE RELATED TO THE PATIENT SAMPLE. PHOSPHATE RESULTS MAY BE AFFECTED IN RARE CASES BY GAMMOPATHY WHICH COULD CAUSE UNRELIABLE RESULTS. PER PRODUCT LABELING: "IN VERY RARE CASES, GAMMOPATHY, IN PARTICULAR TYPE IGM (WALDENSTROM¿S MACROGLOBULINEMIA), MAY CAUSE UNRELIABLE RESULTS."

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

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 FOUR COBAS 8000 C 702 MODULE ANALYZERS. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. SOME VALUES WERE ACCOMPANIED BY DATA FLAGS INDICATING HIGH ABSORBANCE, WHEREAS OTHERS WERE NOT. THE SAMPLE WAS INITIALLY TESTED THREE TIMES ON C 702 ANALYZER SERIAL NUMBER (B)(4), RESULTING WITH PHOSPHATE VALUES OF 0.1 MMOL/L, 0.19 MMOL/L, AND 0.48 MMOL/L. THE SAMPLE WAS REPEATED ON C 702 ANALYZER SERIAL NUMBER (B)(4), RESULTING WITH A PHOSPHATE VALUE OF < 0.1 MMOL/L ACCOMPANIED BY A DATA FLAG. THE ANALYZER AUTOMATICALLY PERFORMED A REPEAT WITH DECREASED SAMPLE VOLUME, RESULTING WITH A VALUE OF 1.2 MMOL/L. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER WITHOUT DILUTION, RESULTING WITH A VALUE OF 1.15 MMOL/L ACCOMPANIED BY A DATA FLAG. THE ANALYZER AUTOMATICALLY PERFORMED A REPEAT WITH DECREASED SAMPLE VOLUME, RESULTING WITH A VALUE OF 1.16 MMOL/L. THE SAMPLE WAS REPEATED ON C 701 ANALYZER SERIAL NUMBER (B)(4), RESULTING WITH A PHOSPHATE VALUE OF 0.17 MMOL/L. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER WITH DECREASED SAMPLE VOLUME, RESULTING WITH A VALUE OF 2.72 MMOL/L. THE SAMPLE WAS REPEATED ON C 702 ANALYZER SERIAL NUMBER (B)(4), RESULTING WITH A PHOSPHATE VALUE OF 1.21 MMOL/L. ON (B)(6) 2020, THE SAMPLE WAS REPEATED ON C 701 ANALYZER SERIAL NUMBER (B)(4), RESULTING WITH A PHOSPHATE VALUE OF 1.36 MMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER WITH DECREASED SAMPLE VOLUME ON (B)(6) 2020, RESULTING WITH A VALUE OF 1.26 MMOL/L. ON (B)(6) 2020, THE SAMPLE WAS REPEATED ON C 701 ANALYZER SERIAL NUMBER (B)(4), RESULTING WITH A PHOSPHATE VALUE OF 0.41 MMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER WITH DECREASED SAMPLE VOLUME ON (B)(6) 2020, RESULTING WITH A VALUE OF 1.92 MMOL/L. ON (B)(6) 2020, THE SAMPLE WAS REPEATED ON C 701 ANALYZER SERIAL NUMBER (B)(4), RESULTING WITH A PHOSPHATE VALUE OF 1.13 MMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER WITH DECREASED SAMPLE VOLUME ON (B)(6) 2020, RESULTING WITH A VALUE OF 1.16 MMOL/L.