MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT PSA ASSAY; 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 03/24/2017

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 (b)(6) guidelines or the 2015 (b)(6).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.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 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." the expected results section of the ifu states that samples from 100 females were tested.100% of the results were between 0.0-4.0 ng/ml with a median psa value of <0.06 ng/ml.Siemens continues to request additional information from the customer to determine if the results the customer is observing are within the expectations for the assay.Advia centaur psa 500t: lot 032272, kit lot 49906272, exp.Date 2017/04/18, date of manufacture 2016/04/18 (b)(4).Advia centaur psa 500t: lot 032273, kit lot 58788273, exp.Date 2017/08/11, date of manufacture 2016/08/11 (b)(4).

Event Description

Customer is moving from an alternate psa method to the advia centaur xpt prostate-specific antigen (psa) assay and has observed higher results for radical-prostatectomy patients and female patients with the advia centaur xpt psa assay.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xpt psa results.

Manufacturer Narrative

Siemens filed mdr 1219913-2017-00086 on april 13, 2017 reporting that a customer is moving from an alternate psa method to the advia centaur xpt prostate-specific antigen (psa) assay and has observed higher results for radical-prostatectomy patients and female patients with the advia centaur xpt psa assay.April 24, 2017 - additional information: siemens received the following information from the customer: the customer has used advia centaur psa lot number 032273 and calibrator lot 67.They have seen the issue with 2 advia centaur xpt systems will all lots and all calibrations.The customer is using greiner vacuette serum tubes with serum separator and clot activator.Three patients that have had radical prostatectomy surgery recover as follows: (b)(6) psa value 0.11 ng/ml (b)(6), (b)(6) psa value 0.04 ng/ml (b)(6), (b)(6) psa value 0.05 ng/ml (b)(6).Other patients with prostate cancer but that did not have radical prostatectomy surgery recover as follows: (b)(6) psa value 0.03 ng/ml (b)(6), (b)(6) psa value 0.09 ng/ml (b)(6), (b)(6) psa value 0.09 ng/ml (b)(6), (b)(6) psa value 0.05 ng/ml (b)(6).A review of the control data provided by the region from january 25th thru march 23rd when using both lots 272 and 273 shows the following recovery and precision.Control (b)(6) bio-rad target 0.200 ng/ml customer mean 0.201 ng/ml total cv 6% bias 1% data points 42; control (b)(6) bio-rad target 13.3 ng/ml customer mean 12.86 ng/ml total cv 4% bias -3% data points 40.Coefficient of variation (cv).Siemens has requested the calibration information from the customer as well as the treatment which the 4 patients that have prostate cancer but did not have radical prostatectomy surgery.Siemens continues to work with the customer.(b)(6).

Manufacturer Narrative

Siemens filed mdr 1219913-2017-00086 on april 13, 2017 reporting that a customer is moving from an alternate psa method to the advia centaur xpt prostate-specific antigen (psa) assay and has observed higher results for radical-prostatectomy patients and female patients with the advia centaur xpt psa assay.Siemens filed mdr 1219913-2017-00086 supplemental 1 on april 24, 2017 with additional information received from the customer.May 24, 2017 - additional information: the customer could not provide any information on the treatment the patients were receiving as the information is confidential.Customer provided calibration information which shows an increase in low calibrator relative light units (rlus) from the calibration on (b)(6) 2017 (3400 rlus) to the (b)(6) calibration (5900 rlus) and (b)(6) calibration (5600 rlus).Siemens is investigating as to whether there were any changes to the system during that time.

Manufacturer Narrative

Siemens filed mdr 1219913-2017-00086 on april 13, 2017 reporting that a customer is moving from an alternate psa method to the advia centaur xpt prostate-specific antigen (psa) assay and has observed higher results for radical-prostatectomy patients and female patients with the advia centaur xpt psa assay.Siemens filed mdr 1219913-2017-00086 supplemental 1 on april 24, 2017 with additional information received from the customer.Siemens filed 1219913-2017-00086 supplemental 2 on may 24, 2017 with information regarding calibrations of the assay.June 26, 2017 - additional information: the customer observed advia centaur xpt psa results that were higher than expected compared to the alternate method that it previously used.After evaluation of the information provided, and based on available information including the urgent field safety notice (b)(4) and the urgent medical device correction (b)(4) described below, and the instructions for use, advia centaur xpt psa reagent lots 032272 and 032273 are performing as intended at this customer's site.Siemens issued an urgent field safety notice (b)(4) and an urgent medical device correction (b)(4) 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 (b)(64 guidelines or the 2015 (b)(4)).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.These guidelines define biochemical recurrence of prostate cancer as a detectable or rising psa value post-radical prostatectomy that is >/=0.2 ng/ml (ug/l) with a second confirmatory level of >/=0.2 ng/ml (ug/l), so the results obtained by the customer do not indicate biochemical recurrence of prostate cancer.As noted in the warning in the intended use section of the advia centaur xpt psa instructions for use, "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 results 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 monitoring 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." additionally, as stated in the limitations section of the instructions for use, "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.(17) patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis.".

• Brand Name: ADVIA CENTAUR XPT PSA ASSAY
• 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: 6489580
• MDR Text Key: 72679518
• Report Number: 1219913-2017-00086
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2017
• Device Model Number: N/A
• Device Catalogue Number: 10310293
• Device Lot Number: 032272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/26/2017
• Supplement Dates FDA Received: 05/10/2017; 06/06/2017; 06/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 1219913-07/28/2016-004-C
• Patient Sequence Number: 1