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

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/21/2015

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant advia centaur xp psa results is unknown.Siemens healthcare diagnostics has requested the patient samples for further testing and investigation.The instrument is performing within specification.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." (b)(4).

Event Description

Discordant advia centaur xp psa results were obtained on samples from two patients.The initial results did not match the repeated results.The initial high results were reported to the physician.Repeat testing was performed at a later date on the patient samples that were frozen.The neat results were below 100ug/l and the diluted results were above 100 ug/l.All medical treatment was stopped according to the biologist.There was no report of adverse health consequences due to the discordant advia centaur xp psa result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2015-00156 on october 14, 2015.12/20/2015 additional information: siemens received two samples for testing and investigation.The patient samples were (b)(6).The patient samples were tested with lot 263 for the high dose hook effect claim.Summary of results: sid: (b)(6).Units: ng/ml , ng/ml.Total psa, neat: > 100 (106) , 74.8.Total psa, diluted (1:100): 6075.5, 11427.0.Free psa : 435.3, 1855.8.Cpsa: 6557.2, 8839.9.% free psa (fpsa/total psa): 7%, 16%.% cpsa (cpsa/total psa): 108%, 77%.Ifu hook claim - pass/fail: pass, fail.The patient sample (b)(6) did not hook back onto the curve.The value was > 100 ng/ml and did not confirm for the high dose hook effect.The patient sample (b)(6) did hook back onto the curve and confirmed for the high dose hook effect as it recovered <100 when tested neat.The value was 74.8 ng/ml.When the patient sample was diluted, the concentration was calculated to be 11,427 ng/ml.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)." siemens has also performed an internal investigation for the advia centaur systems psa high dose hook effect.Based on siemens' internal testing, samples with total psa concentrations between 4200ng/ml (ug/l) and 8400 ng/ml (ug/l) do not assay >100 ng/ml (ug/l) but instead result in falsely depressed concentrations of approximately 50 ng/ml (ug/l) to 94 ng/ml (ug/l).Therefore, siemens issued urgent field corrective action cc 16-05.A.Ous and urgent medical device correction cc 16-05.A.Us on december 2015 informing the customer that the advia centaur systems prostate specific antigen (psa) assay kit lots ending in 263 and above are not meeting the current high-dose hook effect expectation in the instructions for use (ifu).Instructions on actions to be taken by the customer are provided in the customer communication.No further action required.

• Brand Name: ADVIA CENTAUR XP PSA
• Type of Device: PROSTATE SPECIFIC ANTIGEN ASSAY (PSA)
• 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: 5149939
• MDR Text Key: 28258565
• Report Number: 1219913-2015-00156
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2015
• Device Model Number: N/A
• Device Catalogue Number: 06574155
• Device Lot Number: 260, 263, AND 264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2015
• 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
• Removal/Correction Number: 1219913-12-30-2015-004-C
• Patient Sequence Number: 1