MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP PROSTATE SPECIFIC ANTIGEN (PSA); PSA IMMUNOASSAY

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens issued an urgent field safety notice cc 16-17.A.Ous and an urgent medical device correction cc 16-17.A.Us on july 28, 2016 emphasizing to customers that the prostate-specific antigen (psa) values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy (e.G., the 2013 american urological association (aua) guidelines or the 2015 european association of urology (eau)).These guidelines define biochemical recurrence of prostate cancer as a detectable or rising psa value post-radical prostatectomy that is greater than or equal to 0.2 ng/ml (ug/l) with a second confirmatory level of greater than or equal 0.2 ng/ml (ug/l).In a recent study conducted by siemens, the limit of quantitation (loq) level for the advia centaur/xp/xpt psa assay was evaluated, and determined to be 0.04 ng/ml at the level of 20% within laboratory precision.The study confirms that the assay is performing as designed and variability seen is within precision performance expectations.Based on this information and the results provided, the results do not indicate biochemical recurrence of prostate cancer.There is no sample available for additional testing and no additional patient information is available.The instruction for use (ifu) under the intended use section states the following: "this in vitro diagnostic assay is intended to quantitatively measure prostate-specific antigen (psa) in human serum using the advia centaur®, advia centaur xp, and advia centaur xpt systems.This assay is indicated for the measurement of serum psa in conjunction with digital rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 years and older.This assay is further indicated as an aid in the management (monitoring) of patients with prostate cancer." the following warning is also included in the ifu: warning: the concentration of total psa in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The result reported by the laboratory to the physician must include the identity of the assay for total psa used.Values obtained with different assay methods cannot be used interchangeably.If in the course of monitory a patient, the assay method used for determining serial levels of total psa is changed, the laboratory must perform additional testing to confirm baseline values.United states federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician." the ifu under the limitation section states the following:" warning" "do not predict disease recurrence solely on serial psa values." "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." additionally, the limitations section of the ifu states: "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Seventeen (17) patients routinely exposed to animals or animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis." based on the available information the advia centaur xp/xpt psa assay is performing as intended.

Event Description

Customer observed an advia centaur xp prostate-specific antigen (psa) result that was reproducible and elevated compared to alternate methods.The elevated results were reported to the patient who questioned the results.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp psa results.

• Brand Name: ADVIA CENTAUR XP PROSTATE SPECIFIC ANTIGEN (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: 6623613
• MDR Text Key: 77507642
• Report Number: 1219913-2017-00135
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P950021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2017
• Device Model Number: N/A
• Device Catalogue Number: 10310292
• Device Lot Number: 84673275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1219913-07/28/2016-004-C
• Patient Sequence Number: 1
• Patient Age: 83 YR