ADVIA CENTAUR CP PROSTATE-SPECIFIC ANTIGEN (PSA) ASSAY N/A 02676506

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-06 for ADVIA CENTAUR CP PROSTATE-SPECIFIC ANTIGEN (PSA) ASSAY N/A 02676506 manufactured by Siemens Healthcare Diagnostics, Inc..

Event Text Entries

[1973394] A low advia centaur cp psa result was obtained on a patient sample and discordant when compared to the patient's previous psa test history. The physician questioned the result. Repeat testing was performed and the result was elevated. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant psa result.
Patient Sequence No: 1, Text Type: D, B5


[9133645] The cause for the low psa result is unknown. The quality control was within acceptable range. The instrument is performing within specifications. No further evaluation of the device is required. The ifu states in the limitations section: "note: do not interpret levels of psa as absolute evidence of the presence or the absence of malignant disease. Before treatment, patients with confirmed prostate carcinoma frequently have levels of psa within the range observed in healthy individuals. Elevated levels of psa can be observed in patients with nonmalignant diseases. Measurements of psa should always be used in conjunctions with other diagnostic procedures, including information from the patient's clinical evaluation. The concentration of total psa in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity. Total psa determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity. Warning: do not predict disease recurrence solely on serial psa values. "
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1219913-2011-00085
MDR Report Key2114586
Report Source05,06
Date Received2011-06-06
Date of Report2011-05-19
Date of Event2011-05-17
Date Mfgr Received2011-05-19
Date Added to Maude2012-05-25
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 FDA0
Event Location0
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 Use0
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADVIA CENTAUR CP PROSTATE-SPECIFIC ANTIGEN (PSA) ASSAY
Generic NamePSA IMMUNOASSAY
Product CodeNAF
Date Received2011-06-06
Model NumberN/A
Catalog Number02676506
Lot Number224
ID NumberN/A
Device Expiration Date2011-11-24
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS, INC.
Manufacturer AddressTARRYTOWN NY 10591 US 10591


Patients

Patient NumberTreatmentOutcomeDate
10 2011-06-06

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