SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CA 19-9 ASSAY; IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/29/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The cause for the falsely low advia centaur xp ca 19-9 result is unknown.Siemens had the same patient sample retested at two other laboratories.For one laboratory, the patient sample was tested on an advia centaur xpt and the ca 19-9 result was lower.For the other laboratory, the sample was tested on a siemens immulite 2000, and the ca 19-9 result was higher.Siemens is investigating.The warning section of the instructions for use (ifu) states: "the concentration of ca 19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the assay for ca 19-9 used.Values obtained with different assay methods cannot be used interchangeably.If, in the course of monitoring a patient, the assay method used for determining serial levels of ca 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values.The advia centaur ca 19-9 assay is based on the 1116-ns-19-9 antibody available through agreement with fujirebio diagnostics, inc.Assays using antibodies other than 1116-ns-19-9 may give different results." the limitations section of the instructions for use (ifu) states: "warning" "do not use the advia centaur ca 19-9 assay as a screening test or for diagnosis.Do not predict disease recurrence solely on levels of advia centaur ca 19-9.Normal levels of advia centaur ca 19-9 do not always preclude the presence of disease." "note" "do not interpret serum levels of ca 19-9 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed gi carcinoma frequently have levels of ca 19-9 within the range observed in healthy individuals.Additionally, elevated levels of ca 19-9 can be observed in patients with nonmalignant diseases.Measurements of ca 19-9 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation." "the concentration of ca 19-9 in a given specimen determined with assays from different manufacturers can vary because of differences in assay methods, calibration, and reagent specificity.Ca 19-9 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity.Therefore, it is important to use assay specific values to evaluate quality control results.".
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Event Description
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A falsely low advia centaur xp ca 19-9 result was reported by the customer, and considered discordant compared to a higher alternate ca 19-9 test method result.The customer had retested the patient sample at a separate facility with an alternate ca 19-9 test method and the result was higher.The same patient sample was sent to two other laboratories for further ca 19-9 testing.For one laboratory, the patient sample was tested on an advia centaur xpt and the ca 19-9 result was lower.For the other laboratory, the sample was tested on an alternate ca 19-9 test method, and the result was higher.It is unknown if a corrected report was issued by the customer.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp ca 19-9 result.
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Manufacturer Narrative
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Siemens filed the initial mdr 1219913-2016-00128 on 07/29/2016 for a falsely low advia centaur xp ca 19-9 patient result.On 09/07/2016 - additional information: the cause for the falsely low advia centaur xp ca 19-9 patient result in unknown.The patient sample is not available for further investigation.No conclusion can be drawn.Additional customer contact information.(b)(6).The warning section of the instructions for use (ifu) states: "the concentration of ca 19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the assay for ca 19-9 used.Values obtained with different assay methods cannot be used interchangeably.If, in the course of monitoring a patient, the assay method used for determining serial levels of ca 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values.The advia centaur ca 19-9 assay is based on the 1116-ns-19-9 antibody available through agreement with fujirebio diagnostics, inc.Assays using antibodies other than 1116-ns-19-9 may give different results." the limitations section of the instructions for use (ifu) states: "warning" "do not use the advia centaur ca 19-9 assay as a screening test or for diagnosis.Do not predict disease recurrence solely on levels of advia centaur ca 19-9.Normal levels of advia centaur ca 19-9 do not always preclude the presence of disease." "note" "do not interpret serum levels of ca 19-9 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed gi carcinoma frequently have levels of ca 19-9 within the range observed in healthy individuals.Additionally, elevated levels of ca 19-9 can be observed in patients with nonmalignant diseases.Measurements of ca 19-9 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation." "the concentration of ca 19-9 in a given specimen determined with assays from different manufacturers can vary because of differences in assay methods, calibration, and reagent specificity.Ca 19-9 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity.Therefore, it is important to use assay specific values to evaluate quality control results." the instrument is performing within specifications.
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