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U.S. Department of Health and Human Services

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

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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.
 
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Brand NameADVIA CENTAUR XP CA 19-9 IMMUNOASSAY
Type of DeviceIMMUNOLOGICAL 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 Key9555559
MDR Text Key203686625
Report Number1219913-2020-00001
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031393
Number of Events Reported1
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 Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/21/2020
Device Model NumberN/A
Device Catalogue Number10491244
Device Lot Number36974455
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 Received01/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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