Siemens filed initial mdr 1219913-2020-00069 on january 24, 2020.Additional information 02/25/2020: customer confirmed that sample (b)(6) is the same sample as (b)(6) listed in the raw data attachment.Customer confirmed that a correct result of 2 ng/ml was reported to physician for sample (b)(6) ; no other results were reported to physician for this sample.Customer confirmed that sample (b)(6) is from a 61 year old male; no other patient information was provided.Customer confirms that because the reported result was aligned with expectations, this sample was not tested with other methodologies.Additional information 03/06/2020: a discordant high atellica immunoassay (im) alpha fetoprotein (afp) result was obtained for sample (b)(6) on (b)(6) 2020.The sample was repeated on the same instrument with the same reagent pack and calibration.The 3 repeat results align with the physicians expected results for the sample, while the original result and 1 repeat result were elevated.A service request was opened on 1/31/2020, however no service was performed because a precision study was conducted on (b)(6) 2020 with 10 replicates.The results of the precision study were within the criteria documented in the assay instructions for use.As such, the sample was not requested for analysis by siemens.The probable cause of the discordant results is incomplete wash or aspiration, or base dripping in the luminometer, which can be resolved with routine troubleshooting.Siemens investigation is complete.Based on the investigation, no product problem was identified.Mdr 1219913-2020-00070 supplemental report 1 was filed for the repeat discordant result.
|