BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING
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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 09/10/2021 |
Event Type
malfunction
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Event Description
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It was reported that the bd bactec¿ plus aerobic/f culture vials (plastic) produced a molecular false positive.Gram strains were done with no growth present in the culture.There was no indication that results were reported to clinicians, and there was no adverse patient impact.This complaint was created to capture the 2nd of 6 related incidents.The following information was provided by the initial reporter: "customer reporting gram negative id with bcid eplex gp when testing aerobic bottles, but no gram negative grows in culture" "patient #2 bottle lot number: none available.Please provide the date this patient was tested on the bcid eplex gp: (b)(6) 2021.Was eplex result dual positive? yes.Bcid eplex-gp- bacillus cereus group and pan-gn.Bcid eplex-gn- micrococcus pan-gn.Time to positivity? information unavailable.Was any organism seen on the gram stain for this bottle? information unavailable was the bottle plated to media? if so what type? information unavailable did any organism grow in culture? bacillus cereus and micrococcus luteus.No gram negative growth.".
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Manufacturer Narrative
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H.6.Investigation: customer reported a positive id result for bactec media, while using genmark bcid eplex.Investigation cannot be conducted to the retention samples since the lot number is unknown.A complaint history review cannot be conducted relating to the incident lot number and the ¿as reported¿ defect code since batch number is unknown.Complaints for catalog reported have been received.The batch history record could not be reviewed as the lot number is unknown nonetheless batch history records are always reviewed prior to product release.Complaint is unconfirmed.As per product insert a gram-stained smear from culture medium may contain small numbers of nonviable organisms derived from media constituents, staining reagents, immersion oil, glass slides, and specimens used for inoculation.Due to the nature of biological materials in media products and inherent organism variability, the user should be cognizant of potential variable results in the recovery of certain microorganisms.Molecular tests performed on positive blood cultures will detect both viable and non-viable organisms commonly found in culture media.Therefore, molecular test results should be evaluated in conjunction with gram stain results in accordance with standard-of-care practices as well as manufacturer¿s instructions for use.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.H3 other text : see h.10.
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Event Description
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It was reported that the bd bactec¿ plus aerobic/f culture vials (plastic) produced a molecular false positive.Gram strains were done with no growth present in the culture.There was no indication that results were reported to clinicians, and there was no adverse patient impact.This complaint was created to capture the 2nd of 6 related incidents.The following information was provided by the initial reporter: "customer reporting gram negative id with bcid eplex gp when testing aerobic bottles, but no gram negative grows in culture" "patient #2 *bottle lot number: none available.*please provide the date this patient was tested on the bcid eplex gp: sep/10/2021.*was eplex result dual positive? yes.-bcid eplex-gp- bacillus cereus group and pan-gn.-bcid eplex-gn- micrococcus pan-gn.*time to positivity? information unavailable.*was any organism seen on the gram stain for this bottle? information unavailable *was the bottle plated to media? if so what type? information unavailable.*did any organism grow in culture? bacillus cereus and micrococcus luteus.No gram negative growth".
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