SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM INTACT PARATHYROID HORMONE (PTH); RADIOIMMUNOASSAY, PARATHYROID HORMONE
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Model Number N/A |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A customer from outside the united states reported an observation of a discordant elevated intact parathyroid hormone (pth) result on a patient sample on atellica im 1600 analyzer.The initial result was reported to the physician(s), who did not question the result.This sample was repeated on an alternate atellica im 1600 analyzer and the result was lower compared to the initial result.This result was considered as the correct result by the physician(s).A corrected report was issued.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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Event Description
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The customer reported an observation of a discordant elevated intact parathyroid hormone (pth) result on a patient sample on atellica im 1600 analyzer.The initial result was reported to the physician(s), who did not question the result.This sample was repeated on an alternate atellica im 1600 analyzer and the result was lower compared to the initial result.This result was considered as the correct result by the physician(s).A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to this issue.
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Manufacturer Narrative
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Siemens filed the initial mdr 1219913-2024-00008 on 17-jan-2024.Additional information 23-jan-2024: a customer from outside the united states reported an observation of a discordant elevated intact parathyroid hormone (pth) result on a patient sample on atellica im 1600 analyzer.The initial result was reported to the physician(s), who did not question the result.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 sample was repeated on an alternate atellica im analyzer sn# (b)(6), which produced a lower result compared to the initial result.The lower value obtained was 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 result 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 1219913-2024-00007 supplemental 1 was filed for a different date of testing for the same updates.
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