The patient had been diagnosed with thrombocytosis in (b)(6) 2017 and had been treated with hydroxyurea to lower platelets.The customer submitted a smear photo (microscopic image) that was reviewed and platelet (plt) clumps were present.Plt clumps in the specimen may be the cause of plt count underestimation by the analyzer.The plt distribution observed on the microscopic image was uneven.Visual assessment may overestimate the plt count due to the uneven distribution.The analyzer generated flagging for specimen sid (b)(6) that included dispersional data alert for plt (below normal range), suspect band flagging, and red blood cell (rbc) morph flagging.A definitive cause for the different plt results could not be determined.The true plt value for this specific patient sample could not be verified.Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a labeling review, instrument log review, and an instrument service review.No returns were made available from the customer site for this evaluation.No adverse trend was identified for the customer issue.Labeling was reviewed, found to be adequate, and includes instruction to review a stained smear for abnormal rbc or plt morphology and to follow the laboratory review criteria when descriptor/flag rbc morph is observed.Log review did not identify any issues that contributed to the customer issue.Service history review identified no contributing factors to the customer issue.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.
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