Model Number 443624 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: na.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: pma / 510(k)#: k020321 and k040099.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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Event Description
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It was reported while using bd phoenix¿ m50 automated microbiology system there was a misidentification of organism.There was no report of patient impact.The following information was provided by the initial reporter: misidentification of organism.
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Manufacturer Narrative
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After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 1119779-2021-00701 was sent in error.This complaint is not mdr reportable.This product is not sold within the us and bd does not sell a similar product within the us.
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Event Description
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It was reported while using bd phoenix¿ m50 automated microbiology system there was a misidentification of organism.There was no report of patient impact.The following information was provided by the initial reporter: misidentification of organism.
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Search Alerts/Recalls
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