The initial reporter complained of discrepant low results for 1 patient sample tested for elecsys myoglobin (myoglobin) on a cobas e801 module.The initial result was 2042 ug/l.The sample was repeated twice with results of 1880 ug/l and 1753 ug/l.On (b)(6) 2020 the customer repeated the sample using a 1:50 dilution and a 1:100 dilution with results of >150,000 ug/l and 272,737 ug/l respectively.The result of 272,737 ug/l was reported outside of the laboratory.Previous samples from the patient had very high myoglobin results (330,000 ug/l and 195,000 ug/l).No questionable low results were reported outside of the laboratory.The e801 module serial number was (b)(4).
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Section d4: expiration date was updated.The investigation determined the event was due an issue with the patient sample.If myoglobin results are above a certain level, a high dose hook effect may occur causing the myoglobin results to be low.Product labeling states this level is > 30,000 ng/ml.Since earlier results from this patient were known to be high (> 30,000 ng/ml), potentially causing a high dose hook effect, a dilution may be required.Product labeling states: "samples with myoglobin concentrations above the measuring range can be diluted with diluent universal.The recommended dilution is 1:10 (either automatically by the analyzer or manually)." the investigation did not identify a product problem.
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