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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 07/04/2017
Event Type  malfunction  
Manufacturer Narrative
Siemens requested a list of medications that the patient is receiving and also asked if the sample is available for testing. The information and the sample are not available. Root cause of the difference in results between the advia centaur afp and the alternate method with this one sample cannot be determined. The warning in the intended use section of the advia centaur afp instruction for use states: "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. " additionally, the warning in the intended use section of the advia centaur afp instruction for use states: "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. " based on the available information advia centaur afp is performing as intended.
 
Event Description
Customer observed an elevated advia centaur xp alpha-fetoprotein (afp) result compared to an alternate method and the clinical picture. There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp afp result.
 
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Brand NameADVIA CENTAUR XP AFP ASSAY
Type of DeviceAFP IMMUNOASSAY
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS, INC
333 coney street
east walpole MA 02032
Manufacturer Contact
louise mclaughlin
333 coney street
east walpole, MA 02032
5086604381
MDR Report Key6734490
MDR Text Key80804813
Report Number1219913-2017-00159
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K020806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 07/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/22/2018
Device Model NumberN/A
Device Catalogue Number10309980
Device Lot Number20819186
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 Received07/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2016
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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