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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 Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2018
Event Type  malfunction  
Manufacturer Narrative
The cause for the discordant afp results is unknown. Possible sample handling. 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 low advia centaur xpt afp result was obtained for a patient sample when repeated. The initial result had a value greater than 1000 ng/ml the patient sample was repeated on the second advia centaur xpt and the result was high. The patient sample was tested in an alternate method and the result was also high. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant afp results.
 
Manufacturer Narrative
Siemens filed the initial mdr 1219913-2018-00183 on (b)(6) 2018. On (b)(6) 2018: the customer did not request a field service engineer (fse) visit. The problem has not happened again. The advia centaur xpt was upgraded to version 1. 4. The siemens region's upgrading of the advia centaur software to v1. 4 would not have foreseeably addressed a contributing factor to the discordant result. Siemens healthcare diagnostics continues to investigate.
 
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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
MDR Report Key7665925
MDR Text Key113303445
Report Number1219913-2018-00183
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
PMA/PMN Number
K020806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2018
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 Number10309979
Device Lot Number78173196
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

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