G5.Pma / 510(k)#: k020322, k021954, k023273, k023301, k024152, k030677, k031306, k031679, k032131, k033784, k033907, k040006, k040106, k040716, k050089, k050555, k051689, k053241, k060214, k060217, k060218, k060493, k070809, k082538, k082852, 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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H6: investigation summary: this complaint is for misidentification of enterococcus faecalis as listeria monocytogenes when using phoenix panel pmic/id-107 (catalog number 448607) batch number 3268755.The customer did not return panels or but provided phoenix generated lab reports, isolates and binary files for the investigation.The customer provided phoenix lab reports show an isolate identified as leuconostoc species when using the complaint batch.To investigate, three retention panels from the complaint batch were tested using customer returned isolate e.Faecalis on a phoenix m50 machine and evaluated for identification results.In addition, one control panel from the same material but different batch were tested using customer returned isolate e.Faecalis on a phoenix m50 machine and evaluated for identification results.The three panels tested identified the isolate as e.Faecalis, therefore, this complaint is not confirmed for misidentification.A review of the binary files was determined not to be required based on the results of the investigation.The batch history record was satisfactory, and no quality notifications were generated during manufacturing and inspection.A review of complaints revealed three additional complaints on the complaint batch, two of which are related to this defect and unconfirmed.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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