It was reported that the iq200 barcode reader not reading labels, getting light fluctuation errors, and the instrument would not initialize.No change in pt therapy and no adverse effect to pts were reported.Fse replaced fuse f13 lamp, lamina tank, and barcode reader; then tested several samples.System was operational.
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A subject matter expert assisted in the root cause of light fluctuation on the iq200 instrument.The sme stated, a light fluctuation or image error is a flagged sample on the instrument work list.A flagged sample on the instrument work list cannot be released automatically to the lis per iq200 ifu, iq200 series operators manual page 149 p/n: 3004320 rev.C release date: 07/2012.Therefore the risk control with this error could not lead to any patient harm.
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