A customer from outside the united states observed calibration failure due to low calibrator deviation when using the advia centaur xpt sars-cov-2 igg (scovg) assay.There are no allegations of patient harm, changes in treatment, or diagnostic delays due to the observed calibration failure.Siemens healthcare diagnostics is investigating the observed problem.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).
|
A customer from outside the united states reports observation of calibration failure due to low calibrator deviation when using advia centaur xpt sars-cov-2 igg (scovg) assay.Following initial calibration failure, the customer attempted another calibration, but encountered the same error for low calibrator deviation.There are no known reports of patient intervention or adverse health consequences due to the scovg calibration failure.
|
Siemens filed the initial mdr 1219913-2022-00407 on november 21, 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, the type of investigation, investigation finding, and investigation conclusion codes were updated.
|