ADVIA CENTAUR XPT AFP ASSAY N/A 10309979

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-07-06 for ADVIA CENTAUR XPT AFP ASSAY N/A 10309979 manufactured by Siemens Healthcare Diagnostics, Inc..

Event Text Entries

[113303445] 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".
Patient Sequence No: 1, Text Type: N, H10


[113303446] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219913-2018-00183
MDR Report Key7665925
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-07-06
Date of Report2018-10-03
Date of Event2018-06-14
Date Mfgr Received2018-10-02
Date Added to Maude2018-07-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. EIMAN SULIEMAN
Manufacturer Street333 CONEY STREET
Manufacturer CityE. WALPOLE MA 02032
Manufacturer CountryUS
Manufacturer Postal02032
Manufacturer Phone5086604603
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Manufacturer Street333 CONEY STREET
Manufacturer CityE. WALPOLE MA 02032
Manufacturer CountryUS
Manufacturer Postal Code02032
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADVIA CENTAUR XPT AFP ASSAY
Generic NameAFP IMMUNOASSAY
Product CodeLOJ
Date Received2018-07-06
Model NumberN/A
Catalog Number10309979
Lot Number78173196
Device Expiration Date2019-01-25
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS, INC.
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-06

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