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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP 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 08/28/2017
Event Type  malfunction  
Manufacturer Narrative
Siemens filed the initial mdr 1219913-2017-00192 on september 06, 2017. 09/08/2017 additional information: the type of type of blood collection tubes used by the customer are plastic gel barrier tubes manufactured in (b)(4). The customer serially diluted (x3 manual dilution) only sample 1. The result was 255 ng/ml. The patient sample cannot be returned to the manufacturer's site due to china customs issue. Therefore, no further investigation is possible. The patient was healthy, no cancer, and it is unknown if the patient is taking any medications. The cause for the discordant afp results is unknown. The instrument is performing within specifications. No further evaluation of the device is required. Mdr 1219913-2017-00201 supplemental report 1 was filed for the same event.
 
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. " the ifu states in the limitations section: "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed. Additional information may be required for diagnosis. The advia centaur afp assay uses antibodies from two animal species and routinely adds animal sera to its assay components to minimize the interfering response. Mdr 1219913-2017-00201 was filed for the same event.
 
Event Description
A false high advia centaur xp afp result was obtained for a patient sample during physical examination. The patient sample was repeated and the result was high. The patient sample was tested on an alternate method and the result was negative. The negative result was reported to the physician. The negative result was in agreement with the patient's clinical picture. 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 XP 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 Key6845222
MDR Text Key256918817
Report Number1219913-2017-00192
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,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/13/2017
Device Model NumberN/A
Device Catalogue Number10309979
Device Lot Number041183
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 Received09/08/2017
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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