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
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/27/2023 |
Event Type
malfunction
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Event Description
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Report 6 of 8.It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic) that there was a false positive for candia tropical on panel bcid2.No patient impact reported.
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Manufacturer Narrative
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Pma / 510(k)# k113558, k222591.Investigation summary: catalog: 442023.Batch no.: 3110054.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 batch has been previously investigated for the reported defect.No trend identified for batch.Complaint is unconfirmed based on retention samples and batch history record review results.
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Event Description
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Report 6 of 8.It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic) that there was a false positive for candia tropical on panel bcid2.No patient impact reported.
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Manufacturer Narrative
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H.6 investigation summary catalog: 442023 batch no.: 3110054 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 batch has been previously investigated for the reported defect.No trend identified for batch.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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