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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/23/2017
Event Type  malfunction  
Manufacturer Narrative
The siemens customer service engineer (cse) performed a complete performance inspection of the system. Several parts were replaced proactively. The wash manifold was cleaned, fluid lines checked, dark counts were good, dispense volumes were good. Background testing showed no indication of contamination. A precision run of n
=
10 for level 1 and 2 was performed with good precision. The customer was not able to provide information on the blood collection tube, how long it was allowed to clot, and whether it was centrifuged. Insufficient clot time and insufficient centrifugation can lead to particulate matter in a sample that could interfere with the advia centaur xpt afp assay. If samples are transferred to a secondary tube, they should be recentrifuged in the secondary tube before being tested. The cause for the discordant afp results is unknown. Possible sample handling. The instrument is performing within specifications. No further evaluation of the device is required. 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 sample was repeated and the result was low. The patient sample was tested on another advia centaur xpt and the result was low. The low result was reported to the physician. Patient treatment was not 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 Key6939774
MDR Text Key90208450
Report Number1219913-2017-00215
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 10/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/05/2018
Device Model NumberN/A
Device Catalogue Number10309979
Device Lot Number041188
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/25/2017
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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