MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOTICS, INC ADVIA CENTAUR XPT CA19-9; 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 08/13/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant advia centaur xpt ca 19-9 result compared to the alternate method is unknown.Siemens is working with the customer to investigate this issue.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 assay-specific values to evaluate quality control results." mdr 1219913-2019-00243, mdr 1219913-2019-00244 and mdr 1219913-2019-00246 were filed for the same event.

Event Description

Customer observed an elevated advia centaur xpt ca19-9 result that was reproducible on the advia centaur xpt ca19-9 but lower when tested on an alternate method.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xpt ca19-9 result.

Manufacturer Narrative

Siemens filed mdr 1219913-2019-00243, mdr 1219913-2019-00244, mdr 1219913-2019-00245 and mdr 1219913-2019-00246 regarding elevated advia centaur xpt ca 19-9 results compared to an alternate method and the clinical picture.January 8, 2020 - additional information: the sample was not available for further evaluation.Quality control was in range and no issues were noted with other patient samples indicating that the instruments and reagents were performing acceptably.Contributing factors such as sample integrity or preanalytical variables cannot be ruled out.There is a possibility of a heterophilic (hama) interference which can occur in any immunoassay despite the presence of blocker substances such as mouse serum and bovine gamma globulin in the advia centaur ca 19-9 assay.No further testing can be performed.The customer is operational.A potential product issue has not been identified.Siemens filed mdr 1219913-2019-00243 and 1219913-2019-00243 supplemental 1, mdr 1219913-2019-00244 and 1219913-2019-00244 supplemental 1, mdr 1219913-2019-00245 and 1219913-2019-00245 supplemental 1 and mdr 1219913-2019-00246 and 1219913-2019-00246 supplemental 1 were filed for results from testing at different times and sites.

• Brand Name: ADVIA CENTAUR XPT CA19-9
• Type of Device: IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOTICS, INC; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9378046
• MDR Text Key: 208393453
• Report Number: 1219913-2019-00245
• Device Sequence Number: 1
• Product Code: NIG
• UDI-Device Identifier: 00630414574028
• UDI-Public: 00630414574028
• 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
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1