MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CA 19-9; IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

The maintenance on the advia centaur xp systems was up to date.One of the patient samples was run heterophilic antibody blocking tube on the advia centaur xp s/n (b)(4) system on february 10, 2020.The result was 204.05 u/ml.The insignificant change in result post heterophilic antibody blocking treatment does not indicate a presence of heterophilic interference.Siemens requested if sample can be diluted serially 1:2, 1:4, 1:8.The customer performed the dilutions and the results are as follows: advia centaur xp s/n dilution result (b)(4).Siemens healthcare diagnostics is investigating the cause of the discordant ca19-9 results.The ifu states in the limitations section: "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." mdr 1219913-2020-00076 (date 12/31/2019), mdr 1219913-2020-00077 (date 02/03/2020), and mdr 1219913-2020-00078 (repeat result 198.54 u/ml) were filed for the same event.

Event Description

Falsely elevated advia centaur xp ca 19-9 results were obtained on three different samples for the same patient.The results of the first two samples were not questioned by the laboratory, but the patient went to another laboratory and asked for the same test.The result was in the normal range on an alternate method.Then, the patient requested a third sample be tested and the advia centaur xp ca 19-9 result was elevated.The sample was repeated on another advia centaur xp system and the result was elevated.The patient sample was sent to two other laboratories and tested on an alternate method and the atellica solution.The results were lower.There is no indication of a cancer diagnosis or other serious illness with this patient.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ca 19-9 results.

Manufacturer Narrative

Siemens filed the initial mdr on february 27, 2020.Additional information: on (b)(6) 2020, a different blood sample for the patient was tested with a newly installed instrument for alternate method 2.The result was 11.51 u/ml.The results for the patient were expected to be under or at least around the cut-off value of 37 u/ml.The customer's contact name and phone number were provided.Section e1 has been completed with the customer's contact name and phone number.Contact name: dr.(b)(6).March 03, 2020: additional information: a siemens field service engineer (fse) was sent to the customer site for system inspection.The maintenance of the advia centaur xp s/n: (b)(6) was done.Some valves of the w1 rs port of the washing station have been replaced as well as the water/cleaning valves.The washing station was fully checked.The customer successfully calibrated and performed quality control on the system.March 09, 2020: additional information: the maintenance of the advia centaur xp s/n: (b)(6) was done.The reagent probes, luminometer, washing station, water pressure and vacuum tests were successful.In addition, quality control and parallel measurements were also successful.Another freeze-dried sample from the patient was tested on the advia centaur xp s/n: (b)(6) with the tige (total ige) assay and the result was 15.9 u/ml.The patient samples are only stored after testing.These patient samples were stored frozen at -20 celsius.March 10, 2020: additional information: the field application specialist (fas) visited the customer site and performed the verification process on advia centaur xp s/n: (b)(6).March 11, 2020: additional information: each of the tested blood samples from the patient was serum.Siemens healthcare diagnostics continues to investigate.Mdr 1219913-2020-00076 supplemental report 1, mdr 1219913-2020-00077 supplemental report 1, and mdr 1219913-2020-00078 supplemental report 1 were filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00075 on february 27, 2020.Siemens filed the mdr 1219913-2020-00075 supplemental report 1 on march 23, 2020.April 21, 2020 additional information: the customer had a patient with presumed falsely elevated advia centaur xp ca19-9 results.Siemens reviewed available information to determine probable root cause.Quality control (qc) was within range during all testing so this is a sample/patient specific incident.The patient (patient 1) had three different samples that were all elevated above the instructions for use (ifu) cutoff of 37 u/ml.Samples were run on different advia centaur xp instruments at the same site and one sample was repeated - results remained elevated on all testing.Heterophile binding tube (hbt) treatment did not lower the result.Serial dilutions of the sample recovered in a linear fashion.The sample was also run at another site on an atellica and alternate method 2.The atellica ca19-9 remained elevated which is consistent with the advia centaur xp ca19-9 results and is expected because they are the same reagent.The alternate method 2 result was negative/low.The advia centaur xp ca19-9 is standardized to an internal standard and has no claim to match results on the alternate method 2.Differences in method standardization and antibody binding can cause differences in results which is why results from different methodologies cannot be compared.The dilution and hbt data are suggestive of the absence of interfering substances.Siemens cannot rule out elevated ca19-9 due to other unknown factors.The intended use of the assay is not for screening but instead the serial measurement of ca19-9 from patients with known gi malignancies.The ifu states in the intended use section: "for in vitro diagnostic use in the quantitative, serial determination of ca 19-9 in human serum and to aid in the management of patients with gi carcinoma using the advia centaur xp and advia centaur xpt systems.The test is intended for use as an aid in monitoring patients previously treated for gi cancer.Serial testing for ca 19-9 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence.The test is also intended for use as an aid in the management of gi cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment." the ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the ifu states in the limitations section: "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 assay works as specified.No product performance issue is observed.The instrument is performing within specifications.No further evaluation of the device is required.Section h6 results and conclusion codes were updated to reflect the additional information.Mdr 1219913-2020-00076 supplemental report 2, mdr 1219913-2020-00077 supplemental report 2, and mdr 1219913-2020-00078 supplemental report 2 were filed for the same event.

• Brand Name: ADVIA CENTAUR XP CA 19-9
• Type of Device: IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9764174
• MDR Text Key: 224425216
• Report Number: 1219913-2020-00075
• Device Sequence Number: 1
• Product Code: NIG
• UDI-Device Identifier: 00630414574257
• UDI-Public: 00630414574257
• Combination Product (y/n): N
• PMA/PMN Number: K031393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2020
• Device Model Number: N/A
• Device Catalogue Number: 10491379
• Device Lot Number: 36973452
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR