Discordant, falsely elevated hemoglobin (hgb), mean corpuscular hemoglobin (mch), and mean corpuscular hemoglobin concentration (mchc) results were obtained on a patient sample on an advia 560 hematology system.The discordant results were not reported to the physician(s).The following day, a new sample from the same patient was run for hgb, mch, and mchc on the advia 560 hematology system as well as on a non-siemens analyzer.The results on the advia 560 hematology system again recovered falsely elevated, and the results obtained on the non-siemens analyzer recovered lower.The lower results obtained on the non-siemens analyzer were reported, as the correct results, to the physician(s).Due to the one day delay in obtaining the correct hgb result, there was a delay in performing a blood transfusion for the patient.There are no known reports of adverse health consequences due to the discordant hgb, mch, and mchc results, or due to the delay in performing the blood transfusion.
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Siemens filed the initial mdr 2432235-2022-00187 on 17-jun-2022.Additional information (20-jun-2022): subsequent to the initial medical device report (mdr) filed on (b)(6) 2022, siemens learned from the customer that the patient expired due to non-response of the medication (not because of the siemens test results).In fact, many of the siemens test results on (b)(6), 2022 reported in section b5 of the initial mdr were flagged and, as per the advia 560 hematology system operator's guide, the customer repeated the tests.A blood transfusion was performed based on the non-siemens system results.Per siemens' advia 560 hematology system operator's guide, a white blood cell (wbc) count >75 x 10^3 cells/ul is listed to have known interferences with red blood cell (rbc) count, mean corpuscular volume (mcv) and hemoglobin.This patient's wbc was reported as 138 x 10^3 cells/ul.The system is performing according to specifications.No further evaluation of this device is required.The investigation findings and investigation conclusions codes in section h6 were updated to reflect this information.Supplemental mdr 2432235-2022-00186_s1 was also filed for this additional information.
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