MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP PSA ASSAY; PSA IMMUNOASSAY, PRODUCT CODE:

Model Number N/A

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2014

Event Type  malfunction  

Event Description

A false low advia centaur xp psa result was obtained by the customer on a patient sample and the result was reported to the doctor.The low psa result was considered discordant when compared to elevated results on two alternate psa test methods at another site.The patient sample when diluted and repeated on an advia centaur system was elevated.There was no known report of patient treatment being altered or adverse health consequences due to the discordant low advia centaur xp psa test result.

Manufacturer Narrative

The cause for the false low psa patient result on the advia centaur xp system when compared to the elevated results on two alternate psa test methods at another site most likely is due to to a high-dose hook effect.The patient sample when diluted and run on an advia centaur system resulted in an elevated psa test result.The instruction for use under the procedural notes high-dose hook effect states the following: "patient samples with high total psa levels can cause a paradoxical decrease in the rlus (high-dose hook effect).In this assay, patient samples with total psa levels as high as 10,000 ng/ml (10,000 ug/l) will assay greater than 100 ng/ml (100 ug/l).The instruction for use under the limitation section states the following: "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 conjunction 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." the instrument is performing within specifications.

• Brand Name: ADVIA CENTAUR XP PSA ASSAY
• Type of Device: PSA IMMUNOASSAY, PRODUCT CODE:
• 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: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 3890634
• MDR Text Key: 4678325
• Report Number: 1219913-2014-00149
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P950021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Model Number: N/A
• Device Catalogue Number: 02676506
• Device Lot Number: 252
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1