SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP 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 12/19/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The siemens customer service engineer (cse) performed a total service call, verifying all probe adjustment and sample probe to cuvette bottom calibrations.The technical application specialist (tas) worked with the technician to prepare and run new fresh calibrators and quality controla for the ca19-9 assay.The results were in specification.The tas ran a study on a follow up call.The mcm (master curve material) was running low but in range.The cse verified and calibrated reagent probes, replaced ancillary probe and calibrated/adjusted all positions; calibrated ancillary que , primed the all lines, verified acid and base dispense volumes, and primed the lines.Post service, the customer ran the quality control, no issues, level 1 and level 3 were in range.The tas ran a study with the mcm and dilution.The study passed.Siemens healthcare diagnostics is investigating and has requested additional information from the customer.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 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 assayspecific values to evaluate quality control results.".
|
|
Event Description
|
The customer observed a lower ca 19-9 result on the advia centaur xp system after the patient received iv fluids for potassium.The previous result was higher.The patient sample was repeated and the result was higher.The results were reported to the physician and questioned.There are no reports that treatment was altered or prescribed due to the lower than expected advia centaur xp ca 19-9 result.
|
|
Manufacturer Narrative
|
Siemens filed the initial mdr 1219913-2020-00001 on january 06, 2020.January 07, 2020, additional information: siemens has investigated a customer complaint regarding a customer reporting discordant patient results for ca19-9 lot 455 on an advia centaur xp system.The patient sample results from different draws were different within a 2 hour window.The customer requested to know if iv fluids affected patient results.Siemens responded that intravenous (iv) fluids administered to the patient will dilute the ca 19-9 antigen within the patient's serum.The degree of dilution is based on the ratio of amount of iv fluid to the patient total blood volume, and will contribute to lowering ca 19-9 results to that degree.Siemens concludes that the variability of results is confounded by a high dilution of 1:100, repeatability variability, sample tube type variability, administration of iv fluids to the patient between draws, as well as instrument to instrument variability.January 21, 2020: the siemens customer service engineer (cse) performed a thorough evaluation of the system in question.Asides from some minor probe adjustments, the cse also replaced the ancillary probe and associated diluter.That was the only observation made by the cse.Based on the fact that a single result was affected, it is inconclusive to determine if the ancillary probe fluidics played a contributing role in the discordant result.In addition, the ca19-9 assay only uses the ancillary probe for dilutions and does not require an ancillary pre-treatment, so it is not probable that this was a contributing cause.Siemens did not identify a potential product problem.A systemic product non-conformance has not been identified.The instrument is performing within specifications.No further evaluation of the device is required.
|
|
Search Alerts/Recalls
|
|
|