SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CETNAUR XPT CA 19-9 IMMUNOASSAY; IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN,
|
Back to Search Results |
|
Model Number N/A |
Device Problem
No Apparent Adverse Event (3189)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/21/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Siemens healthcare diagnostics is investigating.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the limitations section of the instructions for use 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 ca19-9 can be observed in patients with nonmalignant diseases.Measurements of ca19-9 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." mdr 1219913-2019-00256 was filed for the same event for the advia centaur xpt ca19-9 initial result.
|
|
Event Description
|
A customer observed discordant high results for a patient between advia centaur xpt ca19-9 and an alternate testing platform.The initial result was reported and questioned by the physician.The sample was retested on the same advia centaur xpt on the same day and was also tested with an alternate method on the same day.A corrected report was issued based on the alternate method test result.All controls were in acceptable ranges.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ca19-9 results.
|
|
Manufacturer Narrative
|
Siemens filed mdr 1219913-2019-00266 initial report on december 5, 2019.Siemens filed mdr 1219913-2019-00266 supplemental report on january 3, 2020.Additional information 01/13/2020: the initial issue was reported as abnormally high advia centaur xpt ca19-9 patient results.Siemens cannot definitively determine the cause of this discrepant results.Contributing factors such as sample integrity or preanalytical variables cannot be ruled out.Quality control was in range and no issues were noted with other patient samples indicating that the instrument and reagents were performing acceptably.There is a possibility that this represents a heterophilic (hama) interference which we know can occur in any immunoassay despite the presence of blocker substances (mouse serum and bgg in centaur ca19-9).Siemens received response that the sample was discarded, therefore no further testing can be conducted.A potential product issue has not been identified.No further investigation is required.Mdr 1219913-2019-00256 was filed for the same event for the advia centaur xpt ca19-9 initial result.
|
|
Manufacturer Narrative
|
Siemens filed mdr 1219913-2019-00256 and 1219913-2019-00266 on december 5, 2019 reporting initial and repeat elevated advia centaur xp ca 19-9 results compared to an alternate testing platform.December 10, 2019 - additional information: siemens requested that the sample be tested with a heterophilic blocking tube (hbt), however, the hbt cannot be provided in china.Siemens continues to investigate.Mdr 1219913-2019-00256 and mdr 1219913-2019-00256 supplemental 1 were filed for the initial result and mdr 1219913-2019-00266 and mdr 1219913-2019-00266 supplemental 1 were filed for the repeat result.
|
|
Search Alerts/Recalls
|
|
|