Catalog Number 21342 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Event Description
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A customer from (b)(6) notified biomérieux of a misidentification result when testing an atcc staphylococcus pneumococcus strain (atcc 46619) with the vitek® 2 gp id test kit (ref 21342).Vitek 2 identified the strain as staphylococcus salivarius ssp salivarius.This result was obtained when testing the strain in patient mode rather than qc mode.The strain was also confirmed as streptococcus pneumoniae via vitek ms.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
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Manufacturer Narrative
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The initial report stated: a customer from (b)(6) notified biomérieux of a misidentification result when testing an atcc staphylococcus pneumococcus strain (atcc 46619) with the vitek® 2 gp id test kit (ref 21342).Corrected data: the statement should have read "a customer from france notified biomérieux of a misidentification result when testing an atcc streptococcus pneumoniae strain (atcc 49619) with the vitek® 2 gp id test kit (ref 21342).".
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Manufacturer Narrative
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An investigation was performed for a customer from (b)(6) who reported a misidentification result when testing an atcc streptococcus pneumoniae strain (atcc 49619) with the vitek® 2 gp id test kit (ref 21342).T he customer stated the vitek 2 identified the strain as streptococcus salivarius ssp salivarius.This result was obtained when testing the strain in patient mode rather than qc mode.The strain was also confirmed as streptococcus pneumoniae via vitek ms.The customer did not submit lab reports or the strain for evaluation.The internal biomérieux qc strain was subcultured from a -70° frozen stock to remel tsab agar, incubated at 35-37° c in co2 atmosphere for 18-24 hours.A second subculture was performed and testing included individual organism suspensions with gp cards from the customer's lot (2420528103) and from a random lot (2420587103), in duplicate.The four gp cards tested all gave the expected identification of s.Pneumoniae.No qc deviations or misidentifications were observed.The vitek 2 gp cards performed as expected for this strain.Without the customer's qc strain, lab reports or data submittal it is not possible to further determine the cause of the reported misidentification.
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Search Alerts/Recalls
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