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

Model Number N/A

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2014

Event Type  malfunction  

Event Description

A false low advia centaur xp psa result was obtained on a patient sample.The low result was considered discordant when compared to the patient's previous result from a month ago.Repeat testing was performed with 1:2 dilution and 1:100 dilution.The results were higher.A corrected report was sent to the physician.The patient sample was tested again neat and the result was low.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant advia centaur xp psa result.

Manufacturer Narrative

The cause for the discordant advia centaur xp psa result may be due to the hook effect.The quality control was acceptable.The instrument is performing within specification.No further evaluation of the device is required.The ifu states in the high-dose hook effect section: "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 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 conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.".

• Brand Name: ADVIA CENTAUR XP PSA
• Type of Device: PSA IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; east walpole, MA 02032 ; 5086604603
• MDR Report Key: 3655829
• MDR Text Key: 4281744
• Report Number: 1219913-2014-00055
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/07/2014

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: Health Professional
• Device Expiration Date: 06/06/2014
• Device Model Number: N/A
• Device Catalogue Number: 06574155
• Device Lot Number: 249
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2014
• Initial Date FDA Received: 03/03/2014
• 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