Model Number 441007 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2022 |
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.Initial reporter phone: (b)(6).
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Event Description
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It was reported that bd epicenter¿ single user software patient results were impacted by incorrect results for tetracycline resistance.Customer did not provide information on treatment change to patient or amount of samples affected.The following information was provided by the initial reporter: customer responded that all tetracycline results where the rule was fired between (b)(6) 2022 and (b)(6) 2022 impacted patient results.Tetracycline for esbl isolates was changed to resistant as a result of rule 1487 for patients from (b)(6) 2022 to (b)(6) 2022.
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Manufacturer Narrative
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H.6 investigation summary customer is reporting xpert rule 1487 was fired for tetracycline and minocycline which changes from susceptible to resistant.Bdxpert rule 1487 was created and released in pud v6.71 for customers who wished to suppress cefepime, along with the other cephalosporins when esbl was detected by the phoenix panel, even though the cefepime breakpoints within the pud were aligned with the current clsi breakpoints.Rule 1487 was configured to be default disabled on install and the customer could choose to manually enable the rule, if they wished to use it.Bdxpert rule 1487 was obsoleted in pud v7.01 because it was determined that it was no longer needed per clsi/eucast documentation.At the time of pud v7.01 release, the bdxpert team was not aware that the rule logic was incorrectly inclusive of tetracyclines.This is a confirmed complaint of a bd product.Complaints for results were under statistical control for the month of october.No trends indicated.Device history record review is not required for standalone software.Complaints received for this device and reported condition will continue to be tracked and trended.
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Event Description
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It was reported that bd epicenter¿ single user software patient results were impacted by incorrect results for tetracycline resistance.Customer did not provide information on treatment change to patient or amount of samples affected.The following information was provided by the initial reporter: customer responded that all tetracycline results where the rule was fired between (b)(6) 2022 and (b)(6) 2022 impacted patient results.Tetracycline for esbl isolates was changed to resistant as a result of rule 1487 for patients from (b)(6) 2022.
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Search Alerts/Recalls
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