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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant result is unknown.Siemens healthcare diagnostics is investigating.The interpretation of results of the instructions for use states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the limitations section of the instructions of 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 concentration of total psa in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity.Total psa determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity.".

Event Description

Customer observed a non-reproducible elevated advia centaur xp prostate-specific antigen (psa) assay result compared to repeat results.The initial result was sent to the physician who questioned the result.There are no reports that treatment was altered or prescribed based on the elevated advia centaur xp psa result.

Manufacturer Narrative

Siemens filed mdr 1219913-2019-00252 on november 27, 2019 reporting the customer observation of a non-reproducible elevated advia centaur xp psa result compared to repeat results.December 20, 2019 - additional information: the customer confirmed that psal is the free psa assay and that the units of measure for psal result is ng/ml instead of ng/l as originally reported.Reagent lot 297 was used for all the advia centaur xp psa results.The customer centrifuges samples for 5 minutes at 3500 rpm although the customer was oriented to centrifuge samples for 10 minutes.The sample has not been treated with a heterophilic blocking tube.The sample has been stored frozen and can be sent to siemens for testing.Siemens continues to investigate.

Manufacturer Narrative

Siemens filed mdr 1219913-2019-00252 on november 27, 2019 reporting the customer observation of a non-reproducible elevated advia centaur xp psa result compared to repeat results.Mdr 1219913-2019-00252 supplemental report 1 was filed on january 13, 2020 with additional information.February 10, 2020 - additional information: siemens reviewed the information provided by the customer.The advia centaur xp psa calibration and quality control (qc) data were valid and within insert ranges.The initial sample was not tested with heterophilic blocking tubes (hbt).The customer centrifuged the samples for 5 minutes at 3500 rpm.According to the preparing the samples section of the advia centaur xp psa instructions for use: "before placing samples on the system, ensure that the samples have the following characteristics: samples are free of fibrin or other particulate matter.Remove particulates by centrifugation at 1000 x g for 15-20 minutes.Samples are free of bubbles." while there is insufficient information to determine the cause of the high psa result, siemens cannot rule out preanalytic factors as a possible cause.Preanalytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.Based on the available information the advia centaur xp psa lot 297 is performing as intended and a product performance issue has not been identified.The customer is operational, and no further investigation is required.

• Brand Name: ADVIA CENTAUR XP PROSTATE-SPECIFIC ANTIGEN (PSA)
• Type of Device: PROSTATE-SPECIFIC ANTIGEN (PSA)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9384313
• MDR Text Key: 192239388
• Report Number: 1219913-2019-00252
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 00630414203003
• UDI-Public: 00630414203003
• Combination Product (y/n): N
• PMA/PMN Number: P950021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 10310292
• Device Lot Number: 38094297
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR