BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ PMIC/ID-107; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY
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Model Number 448607 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that bd phoenix¿ pmic/id-107 incorrect identification of enterococcus faecium on an enterococcus faecalis ran (b)(6) 2023.The following information was provided by the initial reporter: customer reports receiving mis-id for enterococcus.
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Manufacturer Narrative
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H.6 investigation summary: this complaint is for mis-identification of enterococcus when using phoenix panel pmic/id-107 (448607) batch number 2264434.The customer did not provide isolate returns, lab reports or panel returns for the investigation.To investigate, two (2) retention samples of the complaint batch were inoculated with qc isolate e.Faecium 4295 and evaluated in a phoenix m50 for identification results.Next, two (2) retention samples of the complaint batch were inoculated with qc isolate e.Faecalis a29212 and evaluated in a phoenix m50 for identification results.All four (4) panels identified their respective isolates accurately; therefore, this complaint is not confirmed.A review of quality notifications revealed no quality notifications for the complaint batch.Complaint trending was performed, and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.H3 other text : see h.10.
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Event Description
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It was reported that bd phoenix¿ pmic/id-107 incorrect identification of enterococcus faecium on an enterococcus faecalis ran 2/5/2023.The following information was provided by the initial reporter: customer reports receiving mis-id for enterococcus.
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Search Alerts/Recalls
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