A review of the analyzer history log from the customer system showed multiple occurrences of sample aspiration and "cuvette wash cycle not completed" errors.The maintenance log shows the wash cuvettes procedure was not performed after the occurrences of the cuvette wash errors as recommended in the operations manual.There were no returns from the customer site for this evaluation.Ticket searches by reagent lots found no other complaints similar to the current issue.The trend review for the last 12 months by list numbers found no adverse or non-statistical trends.The architect clin chem calcium reagent package insert and the architect system operations manual contain information to address the current customer issue.Based on the results of this evaluation and the information from the customer site, a product malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.Use error may have contributed to the customer issue as error codes indicate sample handling issue and/or dirty cuvettes, which may contribute to false results.However, no systemic issue or product deficiency was identified.Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided.
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