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Model Number RUBELLA IGG |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The patient's sample was sent to the manufacturer for investigation.The investigation found a general reagent issue can be excluded.The results reported by the customer are comparable to the results obtained by the investigation.The investigation is ongoing.
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Event Description
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There was a complaint of questionable elecsys rubella igg results for 1 patient tested with a cobas e801 module serial number (b)(4).The questionable results were reported outside the laboratory to the physician.The patient¿s sample was also tested with a diasorin and another unknown method.The patient¿s e801 result on (b)(6) 2021 was 72.1 ui/i, reactive.The patient¿s e801 result on (b)(6) 2021 was 59.4 ui/i, reactive.The patient¿s diasorin result on (b)(6) 2021 was 5.0 ui/i, negative.The patient¿s unknown method result was negative.The elecsys rubella igg used on (b)(6) 2021 was lot 58675801 and had an expiration date of 31-oct-2022.
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Manufacturer Narrative
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The patient sample was received and investigated with the following results: 1.Elecsys rubella igg: 65 iu/ml reactive 2.Elecsys rubella igm: 0.250 coi non-reactive (for information) 3.Platelia rubella igg: negative 4.Neutralization (r&d in-house verification): successful => presence of anti-rubella igg antibodies verified 5.Mirkogen blot rubella igg: negative the successful neutralization clearly supports a true positivity of this sample.The platelia rubella igg, though negative, is at an enhanced level and therefore also slightly supporting a positive result.Interestingly, the blot is totally negative and does not at all support a positive result.Such a constellation was not observed up to now and is extremely difficult to interpret.As there are more results pointing to a content of specific rubella igg in this sample (positive elecsys rubella igg, successful neutralization and enhanced level in the platelia rubella igg) the sample is more likely correct positive in the elecsys rubella igg.The investigation determined the elecsys rubella igg reagent performs within specification.
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Search Alerts/Recalls
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