The customer reported sample identification mismatch on the cell-dyn 3700.Sid (b)(6) was read as sid(b)(6) (seq.5967) by the analyzer.Per the log, it appears that sid (b)(6) was run a second time (seq.5968), but the second run was more in line with the second patient's historical results.The initial run, seq.5967, generated results which match with the repeat run of sid(b)(6) on seq.5972.Return testing was not completed as returns were not available.A review of product historical data did not identify any trends or customer complaints for this issue.A review of the cell dyn 3700 labeling adequately addresses messages and flags that are used to alert the operator.Instructions for interpreting all flags and numeric, scatter, and histogram data should be incorporated into the laboratory's procedure and used to determine the need for further action and/or review of results.Based on this investigation no product deficiency was identified for the cell dyn 3700 sl, list number 02h31-01, serial number (b)(4).
|