Review of the provided patient data confirms the reported event.The initial run showed lower wbc, rbc, hgb and higher plt compared to post transfusion run and initial sample rerun / redraw run two days later.The initial run had instrument generated r flag and platelet clumps system message alerting operator to further review results.The mcv correlated on all runs.Field service engineer (fse) checked the instrument and found no issues.The hgb lamp output was checked and found to be within specifications.The bsv (blood sample valve) and blood detectors were also found to be within specifications.The fse performed repeatability tests 4 times, each within specifications in regards to precision (cv¿s).Controls all recovered within specifications.On (b)(6) 2020 the customer indicated the patient complained of epigastric pain and due to the initial low hgb, the clinician thought the patient was bleeding.There was no information indicating the blood transfusion caused any additional change in patient treatment.It was confirmed the instrument recovered within control before and after this incident, all control results were acceptable.Additionally, the customer indicated ¿this (event) looked like a random error, perhaps caused by sample integrity¿.
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