PHOS2

Additional Manufacturer Narrative

THE CUSTOMER IS ADVISED TO REFER TO THE METHOD SHEET FOR GUIDANCE ON SAMPLE HANDLING. THE CUSTOMER MUST ALWAYS EVALUATE THE CLINICAL PICTURE OF THE PATIENT IN CONJUNCTION WITH THE SAMPLE RESULTS. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM.

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. THE SAMPLE INITIALLY RESULTED IN A PHOSPHATE VALUE OF 0.30 MG/DL ACCOMPANIED BY A DATA FLAG INDICATING A HIGH ABSORBANCE VALUE. THE SAMPLE WAS AUTOMATICALLY REPEATED WITH DECREASED SAMPLE VOLUME, RESULTING IN A VALUE OF 17.51 MG/DL WITH A DATA FLAG. THE 17.51 MG/DL VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE NEXT DAY, THE PATIENT HAD A SECOND SAMPLE COLLECTED AND IT RESULTED IN AN INITIAL VALUE OF 0.30 MG/DL ACCOMPANIED BY A DATA FLAG INDICATING A HIGH ABSORBANCE VALUE. THE SAMPLE WAS AUTOMATICALLY REPEATED WITH DECREASED SAMPLE VOLUME, RESULTING IN A VALUE OF 17.84 MG/DL ACCOMPANIED BY A DATA FLAG INDICATING DECREASED SAMPLE VOLUME. AN ALIQUOT OF THE FIRST SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE IT WAS TESTED ON AN AU8000 SYSTEM, RESULTING IN A VALUE OF 5.1 MG/DL. THE VALUE OF 5.1 MG/DL WAS DEEMED CORRECT. THE SERIAL NUMBER OF THE C 501 ANALYZER IS (B)(4).

Additional Manufacturer Narrative

THE PATIENT WAS DIAGNOSED WITH MULTIPLE MYELOMA. PER PRODUCT LABELING: "IN VERY RARE CASES, GAMMOPATHY, IN PARTICULAR TYPE IGM (WALDENSTRÖM¿S MACROGLOBULINEMIA), MAY CAUSE UNRELIABLE RESULTS."