BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING
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Catalog Number 442023 |
Device Problem
False Positive Result (1227)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/13/2023 |
Event Type
malfunction
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Event Description
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Report 1 of 5 it was reported that bd bactec¿ plus aerobic/f culture vials (plastic) candida tropicalis false positive occurred.The following information was provided by the initial reporter: bactec 442023 molecular false positive what results were reported to clinicians and was patient treatment affected in response? in two cases, candida tropicalis was reported, the other three cases, candida tropicalis result was not reported.What organisms were seen on gram stain? gram positive cocci, yeast (with no growth of c.Tropicalis.C parapsilosis grew in this case); gnr.What organisms grew on culture plate? strep pneumoniae, candida parapsilosis, staph epidermidis, serratia marcescens.
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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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Report 1 of 5.It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) candida tropicalis false positive occurred.The following information was provided by the initial reporter: bactec 442023 molecular false positive.What results were reported to clinicians and was patient treatment affected in response? in two cases, candida tropicalis was reported, the other three cases, candida tropicalis result was not reported.What organisms were seen on gram stain? gram positive cocci, yeast (with no growth of c.Tropicalis.C parapsilosis grew in this case); gnr.What organisms grew on culture plate? strep pneumoniae, candida parapsilosis, staph epidermidis, serratia marcescens.
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Manufacturer Narrative
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H.6 investigation summary.Customer reported a molecular false positive result.Neither photos nor returned good samples were received.Bd was unable to reproduce the customer¿s experience with the bactec product based on our internal procedures and the intended use of the product.Retention samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.Batch history record review did not identify any evidence for which the customer submitted the complaint.A complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.Complaint is unconfirmed based on retention samples and batch history record review results.No corrective actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.
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