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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 08/14/2017
Event Type  malfunction  
Manufacturer Narrative
Siemens requested the patient sample and information on the diagnosis and treatment of the patient. Additional information and the sample were not provided. Siemens service went on site and inspected and tested the advia centaur xp in diagnostics. The system checks were good and within limits. The acid and base dispense properly. A precision study of afp, ca 15-3 and cea showed no issues. A precision study of the sample in question was performed and no issues were observed. Qc passed within limits. Siemens reviewed the customer's calibrations and control values and did not observe any issues. The root cause of the elevated result with this one sample cannot be determined. The sample was not tested on any other lot of reagent. The expected results section of the instructions for use states: "in this study, 98. 4% of the apparently healthy subjects had afp values less than 8. 1 ng/ml. " the table shows that 12 apparently healthy subjects had values between 8. 1 ng/ml and 20. 0 ng/ml. The warning in the intended use section of the instructions 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. " the interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " based on the information available, advia centaur afp lot 188 is performing as intended. No further investigation required.
 
Event Description
Customer observed a reproducibly, elevated advia centaur xp alpha-fetoprotein (afp) result on one patient sample compared to historical results and an alternate method. The physician questioned the result since historically, the result was lower. There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp afp results.
 
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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 Key6845673
MDR Text Key85011903
Report Number1219913-2017-00190
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 09/06/2017
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 Date06/06/2018
Device Model NumberN/A
Device Catalogue Number10309979
Device Lot Number188
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 Received08/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/06/2017
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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