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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP AFP ALPHA-FETOPROTEIN (AFP) IMMUNOASSAY

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP AFP ALPHA-FETOPROTEIN (AFP) IMMUNOASSAY Back to Search Results
Model Number N/A
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2021
Event Type  malfunction  
Manufacturer Narrative
Siemens healthcare diagnostics is investigating the cause of the discordant advia centaur xp afp result. The instructions for use (ifu) states the following, under warnings: "the advia centaur afp assay is not a screening test for cancer and must never be used as such. Afp testing is a safe and effective supplement to patient care when used as part of the overall management strategy for patients undergoing treatment for non-seminomatous testicular cancer or for patients being monitored after therapy is complete. Do not interpret serum afp as absolute evidence of the presence of malignant disease. At time of presentation, patients with confirmed non-seminomatous testicular cancer may have serum afp concentrations within the range observed in healthy individuals. Since elevated afp levels are often found in patients with other malignant and non-malignant conditions, the physician should rule out all other conditions associated with elevated afp levels prior to the use of the advia centaur afp values in non-seminomatous testicular cancer management. Conversely, low concentrations of afp are not necessarily indicative of absence of disease, particularly post-surgery or after chemotherapy. Testicular tumors that are histologically categorized as pure seminoma do not synthesize afp. The advia centaur afp assay, as a useful adjunct in cancer management, is intended for the evaluation of non-seminomatous testicular cancer, or mixed tumors with non-seminomatous elements, but not for pure seminoma. Additionally, several histologic subtypes of non-seminoma either do not synthesize afp (choriocarcinoma) or do so unpredictably (teratoma). Therefore, afp levels should be used concurrently with other diagnostic and clinical patient information. ".
 
Event Description
A customer observed elevated advia centaur xp afp results for one patient which were discordant relative to repeat testing using the same method. The repeat-testing results were within the assay's reference range (<8. 1 ng/ml). The lower results were considered consistent with the patient's clinical picture, and were reported to the physician. There are no allegations of patient harm or changes in treatment resulting from the discordant afp results.
 
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Brand NameADVIA CENTAUR XP AFP
Type of DeviceALPHA-FETOPROTEIN (AFP) IMMUNOASSAY
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict avenue
tarrytown NY 10591 5097
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
333 coney street
east walpole MA 02032
Manufacturer Contact
barry
333 coney street
east walpole, MA 02032
5082985306
MDR Report Key11754086
MDR Text Key248272308
Report Number1219913-2021-00239
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K020806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/03/2021
Device Model NumberN/A
Device Catalogue Number10309980
Device Lot Number231
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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