ACCUPROBE GROUP B STREPTOCOCCUS CULTURE ID KIT

Description of Event or Problem

THE DEVICE IS A GROUP B (B)(6) TEST THAT IS PRIMARILY USED FOR THE DETECTION OF GROUP B (B)(6) AT (B)(6) OF PREGNANCY. A MATERNAL SPECIMEN WAS TESTED ON (B)(6) 2008 WITH THIS DEVICE. THE TEST WAS NEGATIVE FOR GROUP B STREP. THE MOTHER DELIVERED A BABY BOY ON (B)(6) 2009 BY C-SECTION. PER THE REPORT, THE CHILD IMMEDIATELY EXPERIENCED HEALTH PROBLEMS AND WAS DIAGNOSED WITH GBS. THE CHILD WAS HOSPITALIZED FOR 13 DAYS AND TREATED FOR HIGH FEVER, PAIN AND RESPIRATORY DISTRESS. NO INFO IS CURRENTLY AVAILABLE INDICATING RESIDUAL INJURY FOLLOWING HOSPITALIZATION. THE KIT LOT NUMBER ASSOCIATED WITH THIS EVENT HAS NOT BEEN CONFIRMED BY THE LAB THAT PERFORMED THE TESTING, ALTHOUGH, THE REPORTER OF THE INCIDENT HAS INDICATED THIS MAY BE THE SAME LOT NUMBER (555368) THAT WAS SUBJECT TO A RECALL AS DESCRIBED.

Additional Manufacturer Narrative

THE KIT LOT NUMBER ASSOCIATED WITH THIS EVENT HAS NOT BEEN CONFIRMED BY THE LAB THAT PERFORMED THE TESTING, ALTHOUGH, THE REPORTER OF THE INCIDENT HAS INDICATED THIS MAY BE THE SAME LOT NUMBER (555368) THAT WAS SUBJECTED TO A RECALL AS DESCRIBED BELOW. GBS KIT LOT NUMBER 555368 WAS SUBJECTED TO A RECALL ON DECEMBER 30, 2008, DUE TO KITS POTENTIALLY CONTAINING EMPTY, OR PARTIALLY EMPTY TUBES LABELED AS CONTAINING PROBE REAGENT. IF AN EMPTY OR PARTIALLY EMPTY TUBE IS USED FOR THE POSITIVE CONTROL, THIS COULD RESULT IN A DELAY IN CORRECTLY IDENTIFYING THE ISOLATE DUE TO AN INVALID RUN. ALTERNATIVELY, IF A FILLED PROBE TUBE IS USED FOR THE POSITIVE CONTROL WHILE AN EMPTY OR PARTIALLY EMPTY PROBE TUBE IS USED FOR THE PT TESTING, THIS COULD RESULT IN A FALSE NEGATIVE RESULT. ALL REAGENTS IN THE KIT WERE LABELED CORRECTLY. IT IS ESTIMATED THAT BETWEEN 1% AND 5% OF THE TUBES USED TO TEST A SAMPLE FOR GROUP B (B)(6) WERE DEFECTIVE FOR THE IMPACTED LOTS. THERE ARE MULTIPLE POTENTIAL REASONS/CAUSES FOR THE INFANT CONTRACTING GROUP B (B)(6) ALTHOUGH THE MATERNAL SPECIMEN TESTED NEGATIVE. SINCE THE IVD TEST KIT (THE DEVICE) WAS USED AT THE TIME OF TESTING TO PERFORM THE MATERNAL TEST, IT WAS NOT AVAILABLE FOR FURTHER EVAL OR CONFIRMATION.