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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 IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP CA 19-9 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 12/12/2019
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.
 
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Brand NameADVIA CENTAUR XP CA 19-9
Type of DeviceIMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict avenue
tarrytown, ny
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
333 coney street
e. walpole, ma
Manufacturer Contact
eiman sulieman
333 coney street
e. walpole, ma 
6604603
MDR Report Key9764174
MDR Text Key224425216
Report Number1219913-2020-00075
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeHU
PMA/PMN Number
K031393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/02/2020
Device Model NumberN/A
Device Catalogue Number10491379
Device Lot Number36973452
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 Received04/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/02/2019
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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