An internal biomérieux investigation was performed with results as follows: the customer reported testing the isolates from tsab which had incubated for 18-24hrs at 35c.All set up parameters were within recommendations.The customer does not perform a saline sterility check and purchases pre-filled saline tubes from remel.Lab reports were submitted for the four (4) patient isolates as follows.Isolate 1819805109 had a screen shot of a maldi report submitted showing an identification of strep mitis/oralis.Two (2) gp lab reports were submitted.One showed a very good identification of strep.Pseudoporcinus with nine (9) atypical reactions (+: adh1, pyra and -: appa, leua, alaa, dgal, dmal, dmne, sac) for an identification of s.Mitis/oralis.The second lab report gave a result of unidentified and had five (5) atypical reactions (+: amy, dxyl, mbdg, sac and -: dgal) for an identification of s.Mitis/oralis.Isolate 1820406366 was reported by the customer to have been identified by maldi as s.Mitis/oralis but the second screen shot of maldi results that were provided did not match the isolate # (was labeled 18204063665).Four (4) gp lab reports were submitted.One showed a low discrimination call of s.Mitis/oralis, granulicatella adiacens & strep.Pseudoporcinus which is considered a correct call.Three (3) lab reports showed a low discrimination result of g.Adiacens and strep.Pseudoporcinus with five (5) atypical negative reactions (dgal, lac, dmal, dmne, sac) for an identification of s.Mitis/oralis.Isolate 1818304053 had four (4) gp lab reports submitted with one showing an excellent identification of strep.Parasanguinis, one report showing a low discrimination result of s.Mitis/oralis, strep.Pneumoniae and rothia dentocariosa and two (2) reports of either excellent or very good identifications of s.Mitis/oralis.Isolate 1819208351 had two (2) gp lab reports submitted.One lab report showed an excellent identification of strep.Thoraltensis and the other lab report showed an excellent identification of s.Mitis/oralis.Neither isolate had reference identification so an assessment of atypical reactions cannot be performed.Atypical reactions can indicate contamination, mixed culture, compromised viability of the strain, use of non-recommended media or other user set up errors or an atypical strain.However without the strains or raw data it's not possible to further evaluate the cause of the mis-identifications.Gp lot # 2420749203 and 2420732203 met final qc release criteria.These lots passed qc performance testing.
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