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 04/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An outside the united states customer obtained a total human chorionic gonadotropin (thcg) low result on a female patient, on atellica im module.The initial result was not reported to the physician(s).After failing controls in this atellica im module, an impact analysis was performed, with repetition of the sample on other atellica im modules.The repeat results were elevated compared to the initial result.The same sample was again repeated on the initial atellica im module in triplicate, and the results were comparable to the elevated results.A new sample from the same patient was measured on two atellica im modules and the results were low and similar to the initial result.This sample was also repeated on the initial atellica im module and the result remained low.The lower results were considered as correct by the physician(s).Calibration and qc (quality controls) for thcg results were within specifications.The interpretation of results section of the atellica im thcg instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." mdr 1219913-2023-00125 and mdr 1219913-2023-00126 were filed for different updates of the event.Siemens healthcare diagnostics is investigating.
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Event Description
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The customer obtained a total human chorionic gonadotropin (thcg) low result on a female patient, on atellica im module.The initial result was not reported to the physician(s).After failing controls in this atellica im module, an impact analysis was performed, with repetition of the sample on other atellica im modules.The repeat results were elevated compared to the initial result.The same sample was again repeated on the initial atellica im module in triplicate, and the results were comparable to the elevated results.A new sample from the same patient was measured on two atellica im modules and the results were low and similar to the initial result.This sample was also repeated on the initial atellica im module and the result remained low.The lower results were considered as correct by the physician(s).There are no allegations of patient harm, changes in treatment, or delays in diagnosis in association with the discordant atellica im elevated thcg results.
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Manufacturer Narrative
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Siemens filed the initial mdr 1219913-2023-00120 on may 11, 2023.Additional information jun 09, 2023: an outside the united states customer obtained a total human chorionic gonadotropin (thcg) low result (<2.00 miu/ml) on a female patient, on atellica im module (s/n (b)(6), lot 344 on (b)(6) 2023.The initial result was not reported to the physician(s).After failing controls in this atellica im module, an impact analysis was performed, with repetition of the sample on other atellica im modules.The repeat results were elevated compared to the initial result.The same sample was again repeated on the initial atellica im module in triplicate, and the results were comparable to the elevated results.A new sample from the same patient was measured on two atellica im modules and the results were low and similar to the initial result.This sample was also repeated on the initial atellica im module and the result remained low.The lower results were considered as correct by the physician(s).Total human chorionic gonadotropin (thcg) calibration and qc (quality controls) were within specifications for all repeat testing.Based on the available information, cause of the discordant result is consistent with samples handling and/or integrity issue isolated to just one sample.A potential product issue has not been identified.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.Mdr 1219913-2023-00125 supplemental 1 and mdr 1219913-2023-00126 supplemental 1 were filed for the same updates.
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Search Alerts/Recalls
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