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 # 11222908, rev.A, 2016-05) and the expected decrease in patient results.The cause of the event is use error.
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The initial mdr 2432235-2018-00116 was filed on 22-mar-2018.Correction (26-march-2018): section lot # should only list "109".Section report source should include "user facility" not "company representative".Additional information: the kit lot numbers that are associated with this event are: 109, 110, 111, 114, 116, 117, 119, 120, 121, 123.Separate mdrs were filed for the igf-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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