There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g.5: pma/510(k)#: k020322, k021954, k022172, k023273, k023301, k024152, k030677, k031306, k031679, k031679, k032131, k033784, k033907, k040006, k040106, k040716, k050555, k051689, k053241, k060214, k060217, k060218, k060218, k060493, k082538, k082852, k082913, k131331.H.3: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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H.6.Investigation summary: this complaint is for high mic results for vancomycin (va) with staphylococcus aureus when using phoenix panel pmic/id-106 (catalog number 448606) batch number 3192572.The customer did not provide panel returns or phoenix generated lab reports but provided isolates for the investigation.To investigate, four retention samples from complaint batch 3192572 were inoculated with customer returned isolate s.Aureus to observe for va mic results.In addition, two control panels from the same material but different batch were inoculated with customer returned isolate s.Aureus to observe for va mic results.The investigation returned all six panels with satisfactory va mic results; therefore this complaint is not confirmed.The batch history record was satisfactory, and no quality notifications were generated during manufacturing and inspection.A review of complaints revealed no additional complaints on batch 3192572, not related to this defect.Complaint trending was performed, and no trends were identified associated with this defect.Bd will continue to monitor for trends and take action as necessary.
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