An outside the united states customer reports the observation of calibration failure due to low calibrator deviation when using advia centaur xpt sars-cov-2 igg (scovg), lot 015.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 healthcare diagnostics is investigating.Mdr 1219913-2022-00413 were filed for different dates of the event.
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Siemens filed initial mdr 1219913-2022-00414 on nov 23, 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).In section h6, medical device problem code, the type of investigation, investigation finding, and investigation conclusion codes were updated.Mdr 1219913-2022-00413 supplemental 1 was filed for different date of the event.
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