The customer contacted a siemens customer care center and stated that the issue occurred after the centralink software was upgraded.Siemens customer service engineer (cse) and regional support center (rsc) specialist remotely connected to the customer's system, and reviewed the allergy test spe_e1 (cat dander - epithelium) for "unit, patient/control" result selector in method setting.They also reviewed the immulite 2000 xpi's present aspects, translator in specific options, and immulite 2000 xpi communication log, review and edit screen for a patient sample.Upon the rsc specialist's recommendation, the cse changed allergy test spe_e1 (added unit ku/l as aspect, assigned aspect in method as result selector, and synchronized immulite 2000 xpi service and translator).The cse indicated that the required configuration will be applied to other impacted allergy tests.On (b)(6) 2017, the issue was resolved.The cause of the allergy class being sent instead of measured values from centralink to lis is unknown.The device is performing within specifications.No further evaluation of device is required.Mdr 2432235-2017-00663 was filed for the same event.
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The initial mdr 2432235-2017-00662 was filed on 26-dec-2017.Additional information (12-dec-2017): as per the initial mdr, a siemens customer service engineer (cse) indicated that the required configuration will be applied to other impacted allergy tests.The cse verified that the required changes for allergy tests were performed to resolve the issue.The laboratory information system was also adjusted to support the additional information (unit sent as aspect in result record), otherwise the result would not be registered there.
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