D
Patient 1
A CUSTOMER IN THE UNITED STATES NOTIFIED BIOM?RIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK?2 GP TEST KIT (REFERENCE (B)(4)). CUSTOMER CALLED IN WITH ISSUES WHILE RUNNING LISTERIA INNOCUA AND MONOCYTOGENES SPECIES ON THEIR GP CARDS. LISTERIA MONOCYTOGENES IS GIVING LOW DISCRIMINATION ON ONE MACHINE AND UNIDENTIFIED. LISTERIA INNOCUA IS IDENTIFYING LISTERIA WELSHIMERI AND UNIDENTIFIED. THE CUSTOMER STATED THAT THEIR LAST PREVENTATIVE MAINTENANCE WAS IN (B)(6) 2017. A NEW LOT OF GP CARDS WERE RUN ON (B)(6) 2018 AND THE RESULTS WERE AS FOLLOWS: SERIAL NO. (B)(4) = L.INNOCUA 95% AND L.MONOCYTOGENES 95%. SERIAL NO. (B)(4) = L.WELSHIMERI 90% AND L.MONOCYTOGENES 95%. A SECOND RUN WAS PERFORMED ON (B)(6) 2018 AND RESULTS WERE AS FOLLOWS: SERIAL NO. (B)(4) = SIX (6) CARDS WERE RUN ON THIS INSTRUMENT THREE (3) CARDS FOR EACH SPECIES WERE IDENTIFIED AS L.INNOCUA AND L.MONOCYTOGENES SERIAL NO. (B)(4) = SIX (6) CARDS WERE RUN ON THIS INSTRUMENT, THREE (3) CARDS FOR EACH SPECIES WERE IDENTIFIED AS L.INNOCUA AND L.MONOCYTOGENES THERE IS NO PATIENT ASSOCIATED WITH THIS CASE BECAUSE THIS COMPLAINT COMES FROM AN INDUSTRY CUSTOMER. AN ADVERSE IMPACT WAS NOT REPORTED BY THE CUSTOMER. AN INTERNAL BIOM?RIEUX INVESTIGATION WILL BE INITIATED.