This report summarizes 3 malfunction events.A review of the events indicated that three (3) patient samples tested on the echo automated blood bank system produced inaccurate results.A review indicated that one (1) patient sample test using the echo automated blood bank system produced an unexpected false negative result for the anti-k antibody.Two (2) instrument malfunctions produced an rh mistype with one sample producing an unexpected positive for anti-a and a second producing an unexpected positive for the b antigen during forward only abo typing; whereby, the result should have been a+ based on historical results.Subsequent testing of reagent retention lots, reviews of design history records and reagent antigen validation testing of the initial bulk product used for commercial vialing showed acceptable results.Through post event tests and investigations, no specific causes were determined for the malfunctions.
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