The type of blood collection tube used was lithium heparinize plasma tube from bd.The sample was not tested with multi-diluent 11 with the atellica im (b)(6) assay.The patient was not vaccinated for (b)(6).The customer had a patient sample that recovered (b)(6) (198.17 iu/ml) with the atellica im (b)(6) assay on (b)(6) 2019 but was (b)(6) on two alternate methods.When the sample was tested on another atellica im system, it recovered (b)(6) (~200 iu/ml).The sample was also (b)(6) reactive (>1000 index).The data provided by the customer showed the sample recovered 339.98 miu/ml on s/n/ (b)(4) with atellica im (b)(6) lot 109 on (b)(6) 2019 and 301.53 miu/ml on s/n (b)(4) with atellica im (b)(6) lot 117 on (b)(6) 2019.Siemens reviewed the calibration data provided and there is no evidence of a problem.The customer was not able to provide the patient's medical status or a list of medications/supplements the patient is taking.There is no sample that can be sent to siemens for evaluation.The clinical sensitivity and specificity section of the atellica im (b)(6) surface antigen 2 ((b)(6)) instructions for use (ifu) (10995277, revision 03, 2019-04) lists the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88% so a certain number of false (b)(6) results can be expected for this assay.This one false (b)(6) result does not indicate a product problem with atellica im (b)(6) lots 109 and 117.The cause of the false (b)(6) result seen by the customer when using atellica im (b)(6) lots 109 and 117 could not be determined but siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Based on the investigation, no product problem was identified.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the interpretation of results section: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." mdr 1219913-2019-00225, 1219913-2019-00226 and 1219913-2019-00227 were filed for the same event.
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