Catalog Number 04784618190 |
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 02/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).(b)(6).
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Event Description
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The initial reporter questioned false negative elecsys cmv igm immunoassay results on a cobas 6000 e 601 module.The customer provided questionable test results for two patients.Refer to the attachment on the medwatch for all patient data.The e 601 cmv igm results were not reported outside the laboratory.Patient 1¿s first sample was only tested with elisa methodology.The following week, patient 1 had a new sample collected and the customer performed testing on the e 601 and two analyzers that used elisa methodology.Patient 2 was tested on the e 601 and an analyzer with elisa methodology.The e 601 serial number is (b)(4).
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Manufacturer Narrative
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The customer could not provide the patient's sample for further testing to complete the investigation.The customer's calibration and quality control data was requested but were not provided.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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