Catalog Number 05572185190 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/31/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).
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Event Description
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The customer complained of negative results for 1 patient tested for elecsys hsv-1 igg immunoassay (b)(6) and elecsys hsv-2 igg immunoassay (b)(6) on a cobas 8000 e 602 module.This medwatch will cover (b)(6).Refer to medwatch with patient identifier (b)(6) for information on the (b)(6) results.On (b)(6) 2018 the patient was "positive" by a polymerase chain reaction (pcr) test for (b)(6) and 2; the actual results were not provided.The same day the patient was tested by an immulite analyzer and the (b)(6) and 2 results were (b)(6).On (b)(6) 2018 a new sample was obtained and the patient had a "(b)(6)" pcr result for (b)(6) and 2; the actual results were not provided.The sample from (b)(6) 2018 was tested on the immulite analyzer and the (b)(6) and 2 results were (b)(6).The same sample was tested on the e602 module and the (b)(6) result was (b)(6) and the (b)(6) result was (b)(6).The laboratory took the sample from (b)(6) 2018 and ran additional tests for igm by the elisa method.The (b)(4) igm result was (b)(6) (indeterminate) and the (b)(6) result was "(b)(6)" (actual result not provided).The igg avidity test result from the vector-best method was (b)(6).The (b)(6) results from the e602 module were reported outside of the laboratory.There was no allegation that an adverse event occurred.There is an "(b)(6)" result of (b)(6) (units not provided) documented from (b)(6) 2018.This may be a result from the immulite method but this is not clear.It is not clear if this result is from a new sample or from the (b)(6) 2018 sample.Clarification on this has been requested but has not yet been provided.The customer was not having any calibration or qc issues.The e602 module serial number was (b)(4).
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Manufacturer Narrative
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It was clarified that the hvg result of 17.6 coi with a date of (b)(6) 2018 was a repeat of the (b)(6) 2018 sample by the immulite method.
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Manufacturer Narrative
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The calibration and qc recoveries within specified ranges.The assay is performing within specification.The investigation did not identify a product problem.The cause of the event could not be determined.
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Manufacturer Narrative
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The customer provided 3 samples from the patient for investigation.The investigation determined all samples were negative for hsv-1 igg and hsv-1 igg immunoblot results were negative for hsv.
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Search Alerts/Recalls
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