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Model Number RUBELLA IGG |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is ongoing.
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Event Description
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There was an allegation of questionable elecsys rubella igg immunoassay results for 4 patient samples on a cobas pure e 402 analytical unit.For patient 1, the initial rubella igg result was 63.6 iu/ml, interpreted as positive.The sample was sent to a reference laboratory and the result was negative.For patient 2, the initial rubella igg result was 50.1 iu/ml, interpreted as positive.The sample was sent to a reference laboratory and the result was negative.For patient 3, the initial rubella igg result was 23.2 iu/ml, interpreted as positive.The sample was sent to a reference laboratory and the result was negative.For patient 4, the initial rubella igg result was 52.4 iu/ml, interpreted as positive.The sample was sent to a reference laboratory and the result was negative.No questionable results were reported outside of the laboratory.The testing method used by the reference laboratory was requested but not provided.The analyzer serial number is (b)(6).
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Manufacturer Narrative
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Calibration was last performed on (b)(6) 2023 and on (b)(6) 2023.Calibration data was acceptable.The qc recovery data provided was acceptable.The patient samples were submitted for investigation.Patient 1's sample leaked during transport and was unable to be tested.Elecsys rubella igg testing was carried out and all four samples gave reactive results.Elecsys rubella igm testing was carried out and all four samples gave non-reactive results.Platelia rubella igg testing was carried out and sample 2 gave a negative result while samples 3, 4, and 5 gave positive results.Mikrogen recomblot rubella igg testing was carried out and sample 2 gave an indeterminate result while samples 3, 4, and 5 gave positive results.All four samples were able to be neutralized.Samples 3, 4, and 5 were able to be confirmed rubella igg positive.Sample 2's enhanced platelia result, three week bands in the mikrogen testing, and successful neutralization are consistent with the initial positive rubella igg result.The reagent performed within specification.The investigation did not identify a product problem.
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Search Alerts/Recalls
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