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

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456)

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

Event Date 08/21/2015

Event Type  malfunction  

Manufacturer Narrative

The depressed advia centaur psa result when compared to an alternate method and results from the diluted sample is most likely due to a high-dose hook effect.The patient sample when diluted and rested on the advia centaur psa assay yielded elevated results >10000 ng/ml and >10000 ng/ml on an alternate method.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.

Event Description

Customer observed a depressed advia centaur psa sample result compared to the results upon dilution and compared to an alternate method.There are no reports that treatment was altered or prescribed or adverse health consequences due to the depressed advia centaur psa result.

Manufacturer Narrative

Mdr 1219913-2015-00142 was filed on 09/02/2015 reporting a depressed advia centaur psa sample result compared to the results upon dilution and compared to an alternate method.(b)(4).

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2015-00142 on september 16, 2015.Siemens filed mdr 1219913-2015-00142 supplemental 1 on september 29, 2015.On 12/20/2015 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 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 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: 5081656
• MDR Text Key: 26484455
• Report Number: 1219913-2015-00142
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• 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: 032260
• Other Device ID Number: N/A
• 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