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

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 02/16/2015

Event Type  malfunction  

Event Description

Customer observed and advia centaur xp psa result that was low compared to historical results and diluted results.There are no reports that treatment was altered or prescribed or adverse health consequences due to the low advia centaur xp psa result.

Manufacturer Narrative

The cause for the false low advia centaur xp psa result when compared to the elevated historical results and the diluted results is most likely due to a high-dose hook effect.The patient sample when diluted and tested on the advia centaur xp psa assay yielded an elevated results.Siemens has requested the sample for further investigation.The procedural notes on high-dose hook effect of the instructions for use 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 instructions for use 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." the instrument is performing within specifications.

Manufacturer Narrative

Siemens filed 1219913-2015-00055 on (b)(6) 2015.Siemens filed 1219913-2015-00055 supplemental 1 on (b)(6) 2015.Siemens filed 1219913-2015-00055 supplemental 2 on (b)(6) 2015.(b)(6) 2015 additional information: siemens has 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 an urgent field corrective action cc 16-05.A.Ous and an urgent medical device correction cc 16-05.A.Us on (b)(6) 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.

Manufacturer Narrative

Siemens submitted the initial mdr 1219913-2015-00055 on february 18, 2015 reporting an advia centaur xp psa result that was low compared to historical results and diluted results.The cause of the low result is most likely a hook effect.On march 24, 2015 - additional information: siemens received the third sample from the patient and tested it neat and diluted with two lots of advia centaur xp psa reagents.Results are provided in ng/ml: place of testing: customer; draw number: draw 1; reagent lot number: 032259; neat: 87.5.Customer; draw number: draw 1; reagent lot number: 032259; neat: 92.5; 1:100: 8288.Customer; draw number: draw 2; reagent lot number: 032259; neat: 96.4.Customer; draw number: draw 3; reagent lot number: 032260; neat: >100; 1:200: 10824.Siemens; draw number: draw 3; reagent lot number: 032259; neat: 69.5; 1:100: 9405; 1:200: 10097.Siemens; draw number: draw 3; reagent lot number: 032260; neat: 83.2; 1:100: 9434; 1:200: 9997.It is unknown whether the patient is receiving any other medication not related to chemotherapy.The customer reported that they do not have any other samples with results greater than 8000 ng/ml but will provide another 2 mls of the sample from the patient to siemens for additional testing.Siemens continues to investigate the issue.

Manufacturer Narrative

Siemens submitted the initial mdr 1219913-2015-00055 on february 18, 2015 reporting an advia centaur xp psa result that was low compared to historical results and diluted results.The cause of the low result is most likely a hook effect.Siemens filed supplemental report 1 on march 24, 2015 with additional information regarding initial investigation results.June 10, 2015 - additional information: siemens retested the patient sample with reagent lots 032259 and 032260 along side the internal qc release hook sample which has a value of >10,000 ng/ml.Results are provided in ng/ml: (b)(6).Based on the qc hook sample, the assay is performing to specification.This issue appears to patient related.No further investigation is required.

• Brand Name: ADVIA CENTAUR XP 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: 4606468
• MDR Text Key: 5629674
• Report Number: 1219913-2015-00055
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/18/2015

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: 10/02/2015
• Device Model Number: N/A
• Device Catalogue Number: 02676506
• Device Lot Number: 032259&032260
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 03/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/16/2015; 06/15/2015; 01/13/2016
• 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