CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE

Additional Manufacturer Narrative

UNIQUE IDENTIFIER (UDI)#: (B)(4)

Description of Event or Problem

THE CUSTOMER STATED THAT THEY HAVE HAD ISSUES WITH RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH THE CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE (CRPHS) ASSAY EVER SINCE INSTALLATION OF THE COBAS 6000 C (501) MODULE - C501 ON APPROXIMATELY (B)(6)2017. THE CUSTOMER PROVIDED DATA FOR FOUR PATIENT SAMPLES WHICH HAD ERRONEOUS INITIAL RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED ON THE SAME ANALYZER AND THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE FIRST SAMPLE INITIALLY RESULTED AS 2.93 MG/L AND REPEATED AS 4.83 MG/L. THE SECOND SAMPLE, FROM A (B)(6) YEAR OLD FEMALE, INITIALLY RESULTED AS 5.85 MG/L AND REPEATED AS 8.52 MG/L. THE THIRD SAMPLE, FROM A (B)(6) YEAR OLD MALE, INITIALLY RESULTED AS 3.04 MG/L AND REPEATED AS 5.66 MG/L. THE FOURTH SAMPLE, FROM A (B)(6) YEAR OLD MALE, INITIALLY RESULTED AS 2.94 MG/L AND REPEATED AS 4.68 MG/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE C501 ANALYZER SERIAL NUMBER WAS (B)(4). TO RESOLVE THE ISSUE, THE CUSTOMER REPLACED THE REAGENT PACK AND CALIBRATED A NEW REAGENT PACK OF A NEW LOT. THE REAGENT PACK THAT WAS IN USE DURING THE TIME OF THE ISSUE HAD BEEN IN USE FOR 6 MONTHS AND HAD CALIBRATION ISSUES. THE STABILITY OF AN OPENED REAGENT PACK IS 12 WEEKS. THE CUSTOMER CALIBRATED AND RAN QUALITY CONTROLS ON A NEW REAGENT PACK; THESE WERE OK. PRECISION STUDIES WERE PERFORMED AND THESE WERE OK. THE FIELD SERVICE ENGINEER RAN MECHANISM CHECKS AND THESE WERE OK. HE CHECKED THE GEAR PUMP AND VACUUM; THESE WERE OK.

Additional Manufacturer Narrative

THERE HAVE BEEN NO OTHER ISSUES OF THE SAME NATURE AT THE CUSTOMER SITE WITHIN THE PAST 12 MONTHS. INVESTIGATIONS CONCLUDE THAT THE CAUSE OF THE ISSUE WAS USER ERROR AS THE CUSTOMER USED THE REAGENT PACK PAST THE LABELED ON-BOARD STABILITY DATE OF 12 WEEKS.