The customer stated that they have sporadically been getting low results for an unspecified number of patient samples tested with gluc3 glucose hk gen.3 on a cobas 8000 c 702 module.Some samples will have results of 18, 5, or 2.When repeated, these samples have normal results.The customer provided a specific example for one patient sample with an erroneous result.No erroneous results were reported outside of the laboratory.The unit of measure used for gluc3 was not provided.The sample initially resulted with a value of 18, which repeated around 100.No adverse events were alleged to have occurred with the patient.The serial number of the c 702 module is (b)(4).Quality controls were acceptable.The customer declined a service visit.The customer replaced the reagent pack and stated that the issue was resolved.The investigation could not identify a product problem.The cause of the event could not be determined.
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