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 09/03/2021 |
Event Type
malfunction
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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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Event Description
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It was reported that while testing with bd bactec¿ plus aerobic/f culture vials (plastic) a false gram negative result was obtained.Confirmatory culture showed no gram-negative growth.There was no reported patient impact.The following information was provided by the initial reporter: customer reporting bcid eplex- gp testing on 442023 bottles resulted gram negative but no gram negative grew in culture.Patient #2: 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 resulted as streptococcus and pan-gn.Bcid eplex gn- pan gp, pan candida.Time to positivity? 15 hours 40 minutes.Was any organism seen on the gram stain for this bottle? if so what was the organism reported? gram positive cocci in clusters.No gram negative or yeast seen on stain.Was the bottle plated to media? if so what type? used wasp lab.No further information given.Did any organism grow in culture? strep mitis.No gram negative and no candida growth you state for this patient the organism was not reported out, correct? customer did not provide.They just provided that no adverse events were reported.Can you provide the serial number of the bactec the bottle was in when it went positive? the rack? the drawer? customer unable to provide.
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Event Description
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It was reported that while testing with bd bactec¿ plus aerobic/f culture vials (plastic) a false gram negative result was obtained.Confirmatory culture showed no gram-negative growth.There was no reported patient impact.The following information was provided by the initial reporter: customer reporting bcid eplex- gp testing on 442023 bottles resulted gram negative but no gram negative grew in culture.Patient #2 *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 resulted as streptococcus and pan-gn -bcid eplex gn- pan gp, pan candida *time to positivity? 15 hours 40 minutes *was any organism seen on the gram stain for this bottle? if so what was the organism reported? gram positive cocci in clusters.No gram negative or yeast seen on stain.*was the bottle plated to media? if so what type? used wasp lab.No further information given *did any organism grow in culture? strep mitis.No gram negative and no candida growth *you state for this patient the organism was not reported out, correct? customer did not provide.They just provided that no adverse events were reported.*can you provide the serial number of the bactec the bottle was in when it went positive? the rack? the drawer? customer unable to provide.
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Manufacturer Narrative
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H6: investigation summary 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.Customer complaints for molecular false positive have been received but 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 nor further 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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