The customer stated that the cell dyn ruby did not generate rrbc flagging on one sample when run in the cbc mode.The initial wbc result on (b)(6) 2017 run in cbc mode - sid 15ad= 58,800 ul/ repeated in cbc+rrbc mode wbc = 16,300 ul.The patient is a known sickle cell.There was no addiitonal patient information provided.
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The investigation consisted of review of submitted data, review of product historical data, and product labeling.A review of product historical data did not identify any trends or increase in complaint activity.A review of the customer's submitted data showed the resistant rbcs may have been misclassified as lymphocytes in the initial run in cbc test selection.Repeat testing in cbc + rrbc test selection generated the accepted wbc result with no flagging.A review of the cell-dyn ruby system operator's manual provides descriptor/flag - cause and suggested action.The manual also states that nwbc flag suggests the presence of lytic-resistant rbc and if accompanied with another flag that manual smear review is suggested.A malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.However, a systemic issue and/or product deficiency was not identified.
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