Catalog Number 07026889190 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The last calibration was performed on (b)(6) 2020, calibration signals are stable and unsuspicious.The sample was sent to roche for further investigation.It was tested on another cobas e 801 with (b)(6) results.It was also tested with 2 different immunoblots (innolia and microgen) with (b)(6) results.This event occurred in (b)(6).Unique identifier (udi) #: (b)(4).
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Event Description
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The initial reporter received a questionable elecsys (b)(6) immunoassay result for one patient with the cobas e 801 module serial number (b)(4).The initial result from the e801 was 0.0492 coi ((b)(6)).The (b)(6) western blot was (b)(6).The rna analysis with unknown assay was (b)(6).
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Manufacturer Narrative
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The customer's qc recovery was found to be acceptable.Based on calibration and qc data a general reagent issue could be excluded.The sample was tested with abbott architect and ortho hcv 3.0 elisa save which received positive results.The sample was tested with the monolisa hcv ag-ab ultra v2 enzyme immunoassay kit and received negative results.Further clinical history regarding the patient was not provided by the customer.The investigation did not identify a product problem.The cause of the event could not be determined.
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Search Alerts/Recalls
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