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

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2014

Event Type  malfunction  

Event Description

Customer observed inconsistent advia centaur xp psa results between a neat sample and a diluted sample.There are no reports of altered or prescribed treatment based on the inconsistent results.There are no reports of adverse health consequences based on the inconsistent advia centaur xp psa results.

Manufacturer Narrative

The cause for the discordant advia centaur xp psa result may be due to the hook effect of the assay.There are no other reports of inconsistent results between neat and diluted samples at this site.No further evaluation of the device is required.The high-dose hook effect section of the instructions for use (ifu) states: "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 limitations section of the ifu states: "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; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 3674544
• MDR Text Key: 4347302
• Report Number: 1219913-2014-00069
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/18/2014

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: 12/13/2014
• Device Model Number: N/A
• Device Catalogue Number: 06574155
• Device Lot Number: 032253
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 03/12/2014
• 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