The customer received questionable results for four patient samples over several days.Data was only provided for a questionable total bilirubin result for one patient sample.The initial result from a microcup was 0.26 mg/dl.The repeat result from the microcup was 1.38 mg/dl.This result was reported outside the laboratory and was questioned by the doctor.A new sample was collected from the patient and tested on another cobas 6000 c (501) module in a hitachi sample cup with a result of 16 mg/dl.The patient was not adversely affected.The reagent lot number and expiration date were requested but were not provided.The customer performed correlations between the two instruments using the sample cups and they correlated well.The customer tested additional patient samples and qc material for troubleshooting and received incorrect results when the samples were tested in the microcups.The customer checked the sample probe and it was okay.The field service representative found there was an issue with the probe.He replaced and adjusted the sample probe, cleaned and lubricated the rack track, and replaced the sample syringe seals.He ran mechanism checks and diagnostic checks with results within specifications.The customer performed calibration and controls with results within specifications.
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