Catalog Number 444165 |
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 07/20/2023 |
Event Type
malfunction
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Event Description
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It was reported that while using bd epicenter¿ single user software amikacin susceptibility is being incorrectly interpreted.The following information was provided by the initial reproter: customer is reporting amikacin susceptiblity is being incorrectly interpreted by epicenter.It is falsely resulting susceptible on results that should be intermediate to patient charts, so this is very much impacting patient care.
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Manufacturer Narrative
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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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Event Description
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It was reported that while using bd epicenter¿ single user software amikacin susceptibility is being incorrectly interpreted.The following information was provided by the initial reporter: customer is reporting amikacin susceptibility is being incorrectly interpreted by epicenter.It is falsely resulting susceptible on results that should be intermediate to patient charts, so this is very much impacting patient care.
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Manufacturer Narrative
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H.6.Investigation summary: customer is reporting amikacin susceptibility is being incorrectly interpreted by epicenter.Field apps advised customer to check/change amikacin breakpoints in epicenter and to manually change breakpoints and self-validate the new breakpoints.Customer stated they will use the previous year clsi/fda breakpoints.Field apps provided support and resolved the issue.The field apps who provided the customer with support to resolve their issue stated, "epicenter is calling amikacin correctly; the lis was interpreting the results since epicenter is only sending over the mic and the lis is applying the interps." this is not a confirmed complaint of a bd product.Complaints for software were under statistical control for the month of july.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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Search Alerts/Recalls
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