Model 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 05/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) produced 350 false positive cases on patient samples.There was no report of confirmatory testing.No patient impact was reported.The following information was provided by the initial reporter: "false positive cases occurred continuously.".
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Manufacturer Narrative
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H.6.Investigation summary: "catalog 442023.Batch no.1306908.Customer reported a false positive defect.Neither photos nor returned good samples were received.Bd was unable to reproduce customer experience with the bactec product.A false positive response was not observed when retention samples were tested.Batch history records were reviewed, and all testing were within specification for product release.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.Users are cautioned in the package insert under limitation of the procedure: ¿a gram-stained smear from culture medium may contain small number of non-viable organisms derived from media constituents, staining reagents, immersion oil, glass slide and specimens used for inoculation.There are many factors that can influence the false positive rate, including blood volume, blood cell counts, environmental factors, and media lot to lot variations.Complaint is unconfirmed based on retention samples and batch history record review.No correctives 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 investigation process.".
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Event Description
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It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) produced 10 false positive cases on patient samples.There was no report of confirmatory testing.No patient impact was reported.The following information was provided by the initial reporter: "false positive cases occurred continuously.".
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Event Description
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It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) produced 10 false positive cases on patient samples.There was no report of confirmatory testing.No patient impact was reported.The following information was provided by the initial reporter: "false positive cases occurred continuously.".
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Manufacturer Narrative
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The following information has been corrected: b.5 describe event or problem it was reported that bd bactec¿ plus aerobic/f culture vials (plastic) produced 10 false positive cases on patient samples.There was no report of confirmatory testing.No patient impact was reported.The following information was provided by the initial reporter: "false positive cases occurred continuously.".
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Search Alerts/Recalls
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