Catalog Number 07026838190 |
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 11/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The e402 analyzer serial number was (b)(6).The competitor method is abbott.
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Event Description
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The initial reporter questioned positive results from 2 samples from 1 patient tested for elecsys anti-hbe (anti-hbe) on a cobas pure e 402 analytical unit.On (b)(6) 2023 the result from the e402 analyzer was (b)(6) (positive).The sample was sent to a reference laboratory where the result from a competitor method was "negative." the actual result was not provided.On (b)(6) 2023 the result from the e402 analyzer was positive.The actual result was not provided.
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Manufacturer Narrative
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Section b3 was updated.The initial report stated: "on (b)(6) 2023 the result from the e402 analyzer was 0.19 coi (positive)." this should say: "on (b)(6) 2023 the result from the e402 analyzer was 0.19 coi (positive)." the result from the e402 analyzer from 06-dec-2023 was provided: on (b)(6) 2023 the result from the e402 analyzer was 0.18 coi (positive).Section b6 was updated.
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Manufacturer Narrative
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The customer questioned a positive result for an additional patient sample (patient 2) tested for anti-hbe.The result from the e402 analyzer was 0.44 coi (positive).The sample was sent to a reference laboratory where the result by the abbott architect method was "negative." the specific result was not provided.Sample material for patient 1 was submitted for investigation.The sample for patient 2 was not submitted for investigation.For patient 1: the sample was tested on an e402 analyzer with 2 anti-hbe reagent lots (689372 and 758799).The customer's positive results were reproduced: reagent lot 689372: 0.184 coi (positive).Reagent lot 758799: 0.164 coi (positive).The sample was investigated further and it was determined the elecsys anti-hbe was correctly positive.A general reagent or lot-specific issue was not identified.The reagent performs within specification.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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