A customer from outside the united states reported an observation of discordant elevated intact parathyroid hormone (pth) results on multiple patient(s) samples on atellica im 1600 analyzer.The initial results were reported to the physician(s), who did not question the results.All the samples were repeated on alternate atellica im 1600 analyzers and the results were lower compared to the initial results.These results were considered as correct results by the physician(s).A corrected report was issued.Siemens reviewed the calibration and identified that quality control results were outside established ranges.Customer proceeded to report the patient samples despite qc failure.The interpretation of results section of the atellica im intact parathyroid hormone (pth) instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens healthcare diagnostics is evaluating.A separate mdr was filed for a different date of testing for the same issue.
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Siemens filed the initial mdr 1219913-2024-00005 on 17-jan-2024.Additional information 24-jan-2024: a customer from outside the united states reported an observation of discordant elevated intact parathyroid hormone (pth) results on multiple patient(s) samples on atellica im (b)(6) analyzer.The initial results were reported to the physician(s), who did not question the results.On (b)(6) 2023, the customer loaded and calibrated atellica im pth reagent lot 096 on atellica im sn# (b)(6).The calibration was valid although the recovery was low and quality control (qc) with this calibration recovered high and out of insert ranges.Several patient samples were processed with this calibration and needed to be corrected.The calibration, qc and discordant samples used the same reagent pack.These samples were repeated on alternate atellica im analyzers, which produced lower results compared to the initial results.The lower values obtained were deemed correct by the customer.Atellica im sn# (b)(6) was recalibrated with another reagent pack of pth lot 096 and the calibration and controls were acceptable.Based on the available information, the cause of the elevated qc and patient results is consistent with an isolated reagent handling issue.The customer is operational and continues to use pth reagent lot 096 without further concern.In section h6, the investigation finding, and investigation conclusion codes were updated.Mdr 1219913-2024-00006 supplemental 1 was filed for a different date of testing for the same updates.
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