The customer informed siemens that additional patient information and system files are not available.The customer informs that there is no malfunction with the immulite 2000 xpi system and that all maintenance is performed.The customer has stated that the low bias can be explained by the restandardization of the ifg-1 assay and their mistake of not informing the physician(s) about the immulite 2000 igf-i restandardization (customer bulletin # (b)(4), rev.A, 2016-05) and the expected decrease in patient results.The cause of the event is use error.Separate mdrs were filed for the ifg-1 kit lots 109, 110, 111, 114, 116, 117, 119, 120, 121, 123.The following mdrs are associated to this customer and event: 2432235-2018-00116, 2432235-2018-00118, 2432235-2018-00119, 2432235-2018-00120, 2432235-2018-00121, 2432235-2018-00122, 2432235-2018-00123, 2432235-2018-00124, 2432235-2018-00125, 2432235-2018-00126.
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