MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CA 19-9 IMMUNOASSAY 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 12/19/2019

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.

• Brand Name: ADVIA CENTAUR XP CA 19-9 IMMUNOASSAY
• Type of Device: IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; east walpole, MA 02032 ; 5086604603
• MDR Report Key: 9555559
• MDR Text Key: 203686625
• Report Number: 1219913-2020-00001
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/21/2020
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 36974455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial