Description of Event or Problem · 1
ON (B)(6) 2014, BIO-RAD LABORATORIES TECHNICAL SUPPORT DEPARTMENT WAS CONTACTED BY A CUSTOMER REGARDING A PATIENT SAMPLE TESTED ON THE BIO-RAD (B)(6) TEST KIT. THE SAMPLE WAS FROM A PATIENT IN LABOR AND DELIVERY AND WAS REPORTED AS (B)(6). THE CUSTOMER REPORTED THAT THE RESULT WITH (B)(6) EIA ESSAY TESTED THE NEXT DAY ON THE SAME SPECIMEN WAS (B)(6). UPON REVIEW, IT WAS DETERMINED THAT THE CUSTOMER DID NOT FOLLOW THE APPROPRIATE SECTION OF THE PACKAGE INSERT WHEN REPORTING THE RESULT. SPECIFICALLY, THE RESULT WAS REPORTED AS (B)(6) FOR (B)(6) ON (B)(6) RAPID TEST INSTEAD OF (B)(6) AS PER PAGE 23 OF THE (B)(6) RAPID TEST PACKAGE INSERT IN THE INTERPRETATION SECTION. THAT IS, USE OF THE (B)(6) KIT IN A DIAGNOSTIC ALGORITHM REQUIRES BOTH (B)(6) DIAGNOSIS TO BE MADE. ACCORDING TO THE CUSTOMER, ONLY ONE (B)(6) WAS PRESENT. BASED ON THE (B)(6) REPORTED, THE PATIENT'S BABY WAS TREATED WITH ANTI-VIRALS. THE SAMPLES (2 SERUM DRAWS AND 1 PLASMA DRAW) WERE SENT TO BIO-RAD LABORATORIES PRODUCT SUPPORT FOR FURTHER TESTING. THE TESTING CONFIRMED THE (B)(6) RESULT ON THE (B)(6) ASSAY AND THE NON-REACTIVE RESULT OBTAINED ON (B)(6) EIA ASSAY. THE SAMPLES WERE ALSO TESTED ON (B)(6) AND THE RESULTS OBTAINED WERE (B)(6) AND RESULTS OBTAINED WITH THE (B)(6) WERE (B)(6).