An outside the united states (ous) customer contacted the siemens customer care center (ccc) reporting the observation of invalid calibration due to the low-cal deviation with advia centaur xpt sars-cov-2 igg (scovg) lot 015.The customer is unable to run the advia centaur xpt sars-cov-2 igg (scovg) assay, but has a backup alternate test method.Although there is no potential for serious injury in this case, an mdr will be reported to the fda as a requirement of the emergency use authorization (eua).Siemens is investigating.
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Siemens filed the initial mdr 1219913-2022-00395 november 17, 2022.December 13, 2022 - additional information: siemens healthcare diagnostics inc.Investigation confirmed that the failed calibrations are due to the standard s01 value in the master curve card (mcc) for the advia centaur systems lots 19529015 and 27236015, being set at 0.1 index.The s01 value should be 0.01 index.The issue is isolated to the advia centaur systems scovg lots 19529015 and 27236015, smns 1120376 and 1120379.Customers were notified of the issue and instructed to discontinue use of the kits.(us: cc 23-01.A.Us was sent to us customers on 2022-12-16 and outside the us: cc 23-01.A.Ous was sent to customers on 2022-12-16 who have received the advia centaur systems sars-cov-2 igg (scovg) lots 19529015 and 27236015).December 21, 2022 - correction during a review of files, siemens found a typographical error in mdr 1219913-2022-00395 initial report.Section b2 "outcomes attributed to adverse event" has a check for "required intervention to prevent permanent impairment/damage".This was a human error in the form.Siemens confirms that there was no patient injury due to this event.In section h6, the type of investigation, investigation finding, and investigation conclusion codes were updated.
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