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It was reported that while using bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin to culture patient samples the lab observed non-viable organisms.After a gram stain, the patient result was erroneously reported as gram-negative rods.No information was available on how the patient treatment was changed or if treatment was changed.No misdiagnosis or worsening in patient condition was indicated.
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Investigation summary: this product is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued and then labeled by machine per standard operating procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.The batch history record review for batch 9101866 was satisfactory and no notifications were generated during manufacturing and inspection.Formulation, filling and autoclaving processes were within specifications.Qc inspection and testing were satisfactory at time of release.The release testing that is performed on this product does include review of its color and clarity.Samples submitted are examined to ensure that they conform to typical levels.The appearance of this batch was satisfactory per internal procedures.Direct staining techniques are not part of qc release testing for this product.Additionally as part of the release criteria for this product, the bhr is reviewed to confirm the following: the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.All autoclave parameters conformed to the validated cycle parameters for this product.The minimum f0 for this product was met.The complaint history was reviewed and other complaints have been taken on this batch for appearance but are also not confirmed.Retention samples from batch 9101866 were available for inspection.No cap, tube or media defects were observed in 10/10 retention tubes.No appearance or microbial growth defects were found in the retention samples.Returns were received for investigation.One hundred tubes from batch 9101866 in a 100pack carton (#570) were returned in a box with air bubbles.Five of the returned tubes have a labels and have lower than expected fill as if they have been opened and sampled or used.The other 95 tubes have no cap, tube or media defects observed from visual inspection.For investigation of this complaint, retention and return samples were gram stained by two methods: directly dropping the media on a slide and by cytospin preparation.No organisms were observed in either slide prepared from the retention sample.Gram negative rods were observed in both slide preparations for the return sample.Additional retention tubes were incubated at 33-37°c for three days and then moved to a 55- 60°c incubator for an additional seven days.No microbial growth in the form of turbidity in the media was observed after neither the 33-37°c incubation period nor the 55-60°c incubation period.After the 55-60°c incubation, tubes were gram stained, by direct drop, and then plated to non-selective media that was incubated at 33-37°c and 55-60°c for an additional seven days.The gram stains did not show any significant increase in organisms seen compared to non-incubated stains and no microbial growth was observed in any of the plates.Though non-viable organisms were observed in some of the gram stains, this is not an unexpected observation.Bd will continue to trend complaints for contamination or non-viables.This complaint cannot be confirmed.Bd has confirmed the presence of non-viable organisms typically found in culture media constituents.However, because this product does not have a specification for non-viable organisms the complaint cannot be confirmed.Due to the biological nature of the media nonviable organisms can be present.There are statements within the product insert that address the impact of nonviable organisms on the gram staining process in both the precautions and limitations of procedure sections."caution should be exercised in reporting direct gram stain and/or other direct microbiological stain results on tissue specimens processed with this medium due to the possible presence of nonviable organisms in the culture medium." "culture media sometimes contain dead organisms derived from medium constituents, which may be visible in smears of culture media.Other sources of dead organisms visible upon gram staining include staining reagents, immersion oil, glass slides and the specimens used for inoculation.If there is uncertainty about the validity of the gram stain, the culture should be re-incubated for another hour or two and the test repeated before a report is given." bd has initiated capa# 1071036 which is in the investigation stage to determine what has caused the increase in non-viable organisms seen within this media.
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It was reported that while using bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin to culture patient samples the lab observed non-viable organisms.After a gram stain, the patient result was erroneously reported as gram-negative rods.No information was available on how the patient treatment was changed or if treatment was changed.No misdiagnosis or worsening in patient condition was indicated.
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