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Model Number 410895 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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 misidentification results associated with vitek® ms instrument (reference 410895).The customer reported that a gram negative bacillus organism that was lactose positive, isolated from a patient urine sample, was identified as propionibacterium acnes twice.The customer suspected that the identification was incorrect, so they repeated vitek ms testing the following day.The final and correct identification was escherichia coli.The customer confirmed that no incorrect result was reported to the physician, but there was a delay of > 24 hours in reporting.An internal biomérieux investigation will be initiated.
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Manufacturer Narrative
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An internal investigation was performed for a customer from canada that reported misidentification results associated with vitek® ms instrument (reference 410895).The customer reported that a gram negative bacillus organism that was lactose positive, isolated from a patient urine sample, was identified as propionibacterium acnes twice.Conclusion on the system => the system was operational during the tests.=> the spot preparation was quite good.The "all peaks number" from the calibrator strain is quite homogeneous.=> there is a high difference between the "all peaks number" for the first and the second test which is not normal for the same sample.*conclusion on the identification: based on the complaint description, the expected identification is most likely escherichia coli.*suspected cause of the issue : the number of all peaks is low for the first test (58) compared to the second test (103).The "all peak numbers" variation between the two tests could be explained by: - either, a spot preparation variability - or spot made from a new subculture: better protein expression leading to more peaks (masses) detected in the spectra.
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Search Alerts/Recalls
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