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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT AFP ASSAY AFP IMMUNOASSAY

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT AFP ASSAY AFP IMMUNOASSAY 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 09/04/2018
Event Type  malfunction  
Manufacturer Narrative
The cause for the discordant afp results is unknown. Siemens healthcare diagnostics is investigating. The ifu states in the warning section: "warning: the concentration of afp in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the afp assay used. Values obtained with different afp assay methods cannot be used interchangeably. Before changing assay methods, the laboratory must do the following: for prenatal testing, the laboratory must establish a range of normal values for the new assay based on normal serum and amniotic fluid from pregnant women with a confirmed gestational age. For cancer management, the laboratory must perform additional testing to confirm baseline values for patients being serially monitored. United states federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician. Use afp results only as part of the overall clinical evaluation of a patient. Do not use afp results as the only criterion for diagnosis. " the ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. ".
 
Event Description
A false high advia centaur xpt afp result was obtained for a patient sample. The patient was tested a month later for afp and the result was low. The patient sample was tested on an alternate method for confirmation and the result was low. It is unknown if patient treatment was prescribed or altered. There was no report of adverse health consequences due to the discordant afp results.
 
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Brand NameADVIA CENTAUR XPT AFP ASSAY
Type of DeviceAFP 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
e. walpole MA 02032
Manufacturer Contact
eiman sulieman
333 coney street
e. walpole, MA 02032
5086604603
MDR Report Key8323770
MDR Text Key138540490
Report Number1219913-2019-00019
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K020806
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
Report Date 04/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/25/2019
Device Model NumberN/A
Device Catalogue Number10309980
Device Lot Number041196
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 Received03/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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