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Model Number RFIT-ASY-0147 |
Device Problem
False Negative Result (1225)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: on (b)(6) 2024, a positive blood culture sample was tested on the biofire bcid2 panel.The biofire bcid2 panel reported s.Aureus and mrej as detected.The biofire bcid2 panel was positive for s.Aureus and mrej but negative for meca/c, resulting in a not detected result for 'meca/c and mrej (mrsa).' note that the biofire bcid2 panel will only report a detected result for 'meca/c and mrej (mrsa)' if s.Aureus, mrej, and meca/c assay are all positive.It is unknown if the patient was impacted due to the biofire bcid2 panel result or if additional testing was performed.Biofire's investigation into this event is ongoing and further information has been requested from the customer.The full investigation and associated conclusions will be provided in the supplemental report.No remedial action, corrective action, preventive action, or fsca has been deemed necessary at this time.Conclusion: investigation ongoing.
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Event Description
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Summary: a potential false negative methicillin-resistant staphylococcus aureus (mrsa) result on the biofire blood culture identification 2 (bcid2) panel occurred on (b)(6) 2024, after testing a patient blood culture sample.Information regarding additional testing and patient impact is unknown.Biofire has requested further information from the customer and is currently investigating this event.No remedial action, corrective action, preventive action, or field safety corrective action (fsca) has been deemed necessary at this time.
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Manufacturer Narrative
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Investigation: on (b)(6) 2024, a positive blood culture sample was tested on the biofire bcid2 panel.The biofire bcid2 panel reported s.Aureus and mrej as detected.The biofire bcid2 panel was positive for s.Aureus and mrej but negative for meca/c, resulting in a not detected result for 'meca/c and mrej (mrsa).' note that the biofire bcid2 panel will only report a detected result for 'meca/c and mrej (mrsa)' if s.Aureus, mrej, and meca/c assay are all positive.It is unknown if the patient was impacted due to the biofire bcid2 panel result or if additional testing was performed.Biofire's investigation into this event is ongoing and further information has been requested from the customer.The full investigation and associated conclusions will be provided in the supplemental report.No remedial action, corrective action, preventive action, or fsca has been deemed necessary at this time.Update for follow-up report: biofire has requested more information from the customer in order to determine the root cause.The full investigation and associated conclusions will be provided in the final report.Conclusion: investigation ongoing.
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Event Description
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Summary: a potential false negative methicillin-resistant staphylococcus aureus (mrsa) result on the biofire blood culture identification 2 (bcid2) panel occurred on (b)(6) 2024, after testing a patient blood culture sample.Information regarding additional testing and patient impact is unknown.Biofire has requested further information from the customer and is currently investigating this event.No remedial action, corrective action, preventive action, or field safety corrective action (fsca) has been deemed necessary at this time.Update for follow-up report: biofire has requested more information from the customer in order to determine the root cause.The full investigation and associated conclusions will be provided in the final report.
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Search Alerts/Recalls
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