BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
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Catalog Number 448100 |
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 02/14/2024 |
Event Type
malfunction
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Event Description
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It was reported while using the bd phoenix¿ automated microbiology system the user received false results.The expected result was e.Coli, but the patient isolates were either identified as citrobacter farmeri or enterobacter cloacae.No health impact or consequence reported.
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Manufacturer Narrative
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E1.Initial reporter phone #: (b)(6).G5.510(k): there were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g5.Pma / 510(k)#: k020321, k020322, k020323, k040099, and k131331.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Search Alerts/Recalls
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