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 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

All the bio-rad controls for the advia centaur xp ca19-9 assay were within the normal ranges.Siemens healthcare diagnostics is investigating.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." mdr 1219913-2019-00127 was filed for the same event.

Event Description

An advia centaur xp ca 19-9 greater than 700 u/ml result was obtained for a patient sample during physical examination.The patient sample was repeated and run with manual dilution.The results were greater than 700 u/ml.The results were reported to the physician and questioned.The patient sample was tested on two alternate methods and the results were negative.There is no indication of a cancer diagnosis 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 1219913-2019-00128 on july 9, 2019.Siemens filed the mdr 1219913-2019-00128 supplemental report 1 on august 12, 2019.08/21/2019 additional information: the initial issue was reported as a discordant result observed between the advia centaur xp ca19-9 assay and alternate ca19-9 testing platforms.Based on the information provided there is a possibility that the patient has an extremely strong heterophilic interference.The sample was treated and remeasured with heterophile binding tubes, and the results were still high out of the analytical measuring range of the assay.Based on the limitations section in the scantibodies hbt ((heterophilic blocking tube) ifu, there may be some samples with extremely strong heterophilic interference.In such cases the hbt may not be able to block all of the assay interference.Because there no sample remaining, root cause cannot be definitively determined with the provided information.Further investigation is not possible with the available information.No systemic product non-conformance is identified with the supplied information.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00127 supplemental report 2 was filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr (b)(4) on (b)(6)2019.07/24/2019 additional information: the customer does not have any remaining sample for further testing.The sample was tested using hbt (heterophilic blocking tube) with the result >700.Siemens healthcare diagnostics continues to investigate.Mdr 1219913-2019-00127 supplemental report 1 was 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 10591 5097
• MDR Report Key: 8771528
• MDR Text Key: 151749811
• Report Number: 1219913-2019-00128
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2019
• Device Model Number: N/A
• Device Catalogue Number: 10491379
• Device Lot Number: 38008441
• Date Manufacturer Received: 08/20/2019
• Patient Sequence Number: 1
• Patient Age: 30 YR