CAPTIA¿ SYPHILIS (T. PALLIDUM) IGG

Description of Event or Problem

BIO-RAD TECHNICAL SUPPORT WAS CONTACTED ON (B)(6) 2018 BY A BIO-RAD ACCOUNT MANAGER ON BEHALF OF THE CUSTOMER AT CERRITOS REFERENCE LAB. THE CUSTOMER HAD A QUESTION AS TO HOW THEY SHOULD BE REPORTING RESULTS FOR CAPTIA¿ (B)(6). THE CUSTOMER HAD SWITCHED FROM RPR TESTING TO CAPTIA¿ (B)(6) IGG TESTING DURING THE THIRD WEEK OF (B)(6) 2018, AND THE CUSTOMER WAS REPORTING THE CAPTIA¿ SYPHILIS (T. PALLIDUM) IGG RESULTS OUT AS RPR RESULTS. BIO-RAD TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT THEY HAVE BEEN REPORTING OUT THE RESULTS INCORRECTLY, AND PROVIDED THE INFORMATION AS TO HOW THE RESULTS SHOULD BE REPORTED. AS PART OF THE INCIDENT INVESTIGATION BIO-RAD TECHNICAL SUPPORT DISCOVERED THAT THE CUSTOMER WAS RUNNING CAPTIA¿ (B)(6) IGG FOR TESTS THAT WERE ORDERED AS RPR, AND THAT THE TESTS WERE REPORTED AS RPR. THE CUSTOMER REPORTED THAT THEY HAVE SENT A LETTER OUT INFORMING ALL OF THEIR CLINICS OF THE SITUATION, AND THAT THE CUSTOMER WILL TAKE CORRECTIVE ACTION TO RESOLVE THE INCIDENT. THIS INCIDENT IS USER ERROR AS THE CUSTOMER DID NOT PERFORM THE TEST THAT WAS ORDERED BY THE PHYSICIAN, AND THE CUSTOMER REPORTED OUT RESULTS INCORRECTLY. BECAUSE RESULTS WERE REPORTED OUT INCORRECTLY THERE IS POTENTIAL FOR HARM TO THE PATIENT DUE TO DELAYED TREATMENT OR MISDIAGNOSIS.