Device investigation: a nova biomedical technician performed a field service support follow-up visit to the user facility, and during inspection of the analyzer, the technician found that the sample probe s-line was kinked.The technician replaced the sampler assembly to correct the issue.Upon examination of the returned s-line to the manufacturer, a break was observed in the kinked section of the s-line.This break would prevent flow, cause errors, and the analyzer would not calibrate.Therefore, it is highly unlikely that the break was present during the time of the discrepant calcium results.Device history reviews (dhrs) were performed on the analyzer, s-line, and reference cartridge batches.No abnormalities were observed, and the dhrs indicated the released product met all specifications.Based on the available information, the complaint could not be confirmed.
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