Mdr 1219913-2019-00253 was filed on november 27, 2019 reporting an elevated result with atellica im 1300 creatine kinase mb (ckmb) compared to a result generated with a different lot of atellica im ckmb calibrators.November 27, 2019 - additional information: the customer confirmed that the samples were frozen within 48 hours.Siemens reviewed the information provided to determine probable cause.The customers qc ((b)(6) 67610t) was within insert limits with calibrator 73 and calibrators 80/82.At the time the complaint came in, cal lot 73 had already expired so no testing could be done internally between cal lot 73 and cal lots 80 and 82.Siemens ran the current calibrator lot 82 with reagent lot 229 to verify it meets accuracy by recovery standards.(b)(6) lot 67612t qc, in-house medical decision pool samples (mdp), and ckmb master curve material (mcm) were used.The testing included three calibration events and samples run in replicates of 3 on each calibration.All replicates of qc, mdp, mcm samples were within acceptable limits.The customers patient correlation (n=8 patients) did show a positive shift from cal73 to cals 80 and 82 however no samples changed clinical interpretation based on the ifu cutoff of 5 ng/ml.Some lot to lot variability is inherent in all immunoassays.No product performance issue was confirmed.The customer is operational.
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