TINA-QUANT C-REACTIVE PROTEIN IV

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C702 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH TINA-QUANT C-REACTIVE PROTEIN IV ON A COBAS 8000 C702 MODULE. THE CUSTOMER NOTED THAT BOTH PATIENT AND QUALITY CONTROL RECOVERY HAVE INCREASED SIGNIFICANTLY. AFTER RE-CALIBRATION AND QUALITY CONTROL TESTING, THE REAGENT PERFORMS ACCEPTABLY. ELEVEN EXAMPLES WERE PROVIDED OF PATIENT SAMPLES WITH DISCREPANT CRP RESULTS. THE FIRST SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 115.94 MG/L AND IT REPEATED AS 84.3 MG/L. THE SECOND SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 126.18 MG/L AND IT REPEATED AS 94.4 MG/L. THE THIRD SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 128.51 MG/L AND IT REPEATED AS 96.3 MG/L. THE FOURTH SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 129.46 MG/L AND IT REPEATED AS 99.2 MG/L. THE FIFTH SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 139.06 MG/L AND IT REPEATED AS 102.6 MG/L. THE SIXTH SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 144.64 MG/L AND IT REPEATED AS 107.6 MG/L. THE SEVENTH SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 144.87 MG/L AND IT REPEATED AS 108 MG/L. THE EIGHTH SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 149.54 MG/L AND IT REPEATED AS 107 MG/L. THE NINTH SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 167.21 MG/L AND IT REPEATED AS 124.6 MG/L. THE TENTH SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 186.69 MG/L AND IT REPEATED AS 135.2 MG/L. THE ELEVENTH SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 409.03 MG/L AND IT REPEATED AS 308.2 MG/L.