Catalog Number 848 900 010 |
Device Problem
Incorrect Or Inadequate Test Results (2456)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This is our initial report on this incident.
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Event Description
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The customer reported discrepant test results on a patient sample known as anti-kell when testing on tango optimo.The sample showed initially negative test results with screening cell #1 (biotestcell 3).After recollecting the sample and testing it on the second testing day with biotestcell 3 , the sample showed a positive reaction (2+).They repeated two samples from the day before and obtained a +/- test on the screening cells.The customer returned the supposedly defective product (biotestcell 3), the used ahg for solidscreen ii plates (scii) and the two samples that had caused the discrepant results for investigational testing.Our quality control laboratory tested the complained biotestcell 3 lot # 8727011-00 in comparison with the retained current lot biotestcell 3 # 8731021-00 with different samples, controls and with the patient samples provided by the customer.Additionally the ahg for sc ii was tested by titration in parallel to the retained sample and a reference lot.The patient samples were clearly identified to have an anti-kell.All positive and negative reactions were correct for antibody screen.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed the correctly function of the allegedly defective lot biotestcell 3, #8727011-00.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot.Following our sop the complaint has to be classified as not confirmed because the allegedly defective product worked as expected and the provided samples were clearly identified to be positive for anti-kell.The affected tango optimo was inspected by one of our field service engineer.From today´s perspective the affected tango optimo was confirmed to run within specifications.The root cause analysis is still ongoing.
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Manufacturer Narrative
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This is our final report on this incident.
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Event Description
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The customer reported discrepant test results on a patient sample known as anti-kell when testing on tango optimo.The sample showed initially negative test results with screening cell #1 (biotestcell 3).After recollecting the sample and testing it on the second testing day with biotestcell 3 , the sample showed a positive reaction (2+).They repeated two samples from the day before and obtained a +/- test on the screening cells.The customer returned the supposedly defective product (biotestcell 3), the used ahg for solidscreen ii plates (scii) and the two samples that had caused the discrepant results for investigational testing.Our quality control laboratory tested the complained biotestcell 3 lot # 8727011-00 in comparison with the retained current lot biotestcell 3 # 8731021-00 with different samples, controls and with the patient samples provided by the customer.Additionally the ahg for sc ii was tested by titration in parallel to the retained sample and a reference lot.The patient samples were clearly identified to have an anti-kell.All positive and negative reactions were correct for antibody screen.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed the correctly function of the allegedly defective lot biotestcell 3, #8727011-00.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot.The affected tango optimo was inspected by one of our field service engineers.It was confirmed that the instrument is working according to specification.Log file does not indicate an error during processing of the sample.
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Search Alerts/Recalls
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