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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

It is not a routine step in the advia centaur xp and alternate method assays to use peg-6000 treatment.The customer performed peg-6000 treatment because hbt (heterophilic blocking tube) is not available at the customer site.All biorad controls with psa were within the normal ranges.The type of blood collection tube is being used is plastic serum tubes made in china.Human serum can not be sent to the manufacturer's site for further investigation due to china customs issues.Siemens healthcare diagnostics is investigating.The ifu states in the interpretation results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." 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.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.".

Event Description

Discordant high advia centaur xp psa diluted values were obtained for a patient sample during physical examination.The patient sample was tested on an alternate method and the result was normal.The high advia centaur xp psa diluted values were reported to the physician and questioned.A corrected report was issued.The results from the alternate method agree with the clinical picture of the patient.There is no indication of a cancer diagnosis with this patient.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant psa result.

Manufacturer Narrative

Siemens filed the initial mdr on september 5, 2019.09/23/2019 additional information: customer performed sample dilution of multiple factors (1:2, 1:4 and 1:8) and the psa values were lower with each higher dilution factor.In addition, the sample was treated with peg-6000 and the result post treatment was 1 ng/ml.The discordant values may be due to an unknown interference in the sample.Immunoassays are subject to a number of interferences including those caused by endogenous antibodies.Interference can occur because of heterophile antibodies, anti-animal antibodies and auto antibodies.As described in the advia centaur systems psa instructions for use (ifu) 10629889_en rev.W, 2019-08: "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed." the customer could not provide the patient's medical status (e.G.Cancer stage) or a list of medications/supplements the patient might be taking.Based on the available information the advia centaur xp psa lot: 032295 is performing as intended.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP PSA
• Type of Device: PSA IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8964470
• MDR Text Key: 214798126
• Report Number: 1219913-2019-00158
• Device Sequence Number: 1
• Product Code: MTF
• UDI-Device Identifier: 00630414202990
• UDI-Public: 00630414202990
• Combination Product (y/n): N
• PMA/PMN Number: P950021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2020
• Device Model Number: N/A
• Device Catalogue Number: 10310293
• Device Lot Number: 73483295
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR