Catalog Number 07027796190 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The calibration and qc results were within range.Sample from the patient was received for further investigation and the customer's results were reproduced.The sample was tested on an e801 module: rubella igm result with reagent lot 523730 was 0.773 coi (non reactive).Rubella igg result with reagent lot 533269 was 16 iu/ml (reactive).A general reagent issue was excluded and no product problem was found.The investigation is ongoing.
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Event Description
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There was an allegation of a questionable elecsys rubella igm immunoassay result from cobas e801 module serial number (b)(4).On (b)(6) 2021, the elecsys rubella igm result was 0.599 coi (non-reactive).On (b)(6) 2021, the elecsys rubella igm result was 0.598 coi (non-reactive).On (b)(6) 2021, the elecsys rubella igm result was 0.617 coi (non-reactive).On (b)(6)2021, the result from another laboratory by elisa method was positive.All results were from the same patient sample.It was not known if any questionable result was reported outside of the laboratory.
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Manufacturer Narrative
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The investigation determined the results provide evidence that the correct result for the sample was likely positive for rubella igm.The results are consistent with a fresh infection of the patient.Per product labeling, specimens taken very early in the acute phase of infection may not contain detectable amounts of rubella igm antibodies.It was determined there was no malfunction of the reagent.
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Search Alerts/Recalls
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