MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA); TOTAL PROSTATE SPECIFIC ANTIGEN IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report a discordant, high atellica im prostate-specific antigen (psa) result obtained on a patient sample.The system's auto-check data was reviewed, and it was observed that the secondary vacuum calibration was below the target value.Siemens is investigating.The instructions for use (ifu) states under the interpretation of results section the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instructions for use (ifu) states under the limitations section the following: "warning do not predict disease recurrence solely on serial psa values.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.".
Event or Problem Description
A discordant, high atellica im prostate-specific antigen (psa) result was obtained on a patient sample and questioned by the physician(s).The patient was referred to an alternate laboratory for psa testing, resulting lower.A new blood draw sample was obtained on the patient, tested on the atellica im prostate-specific antigen (psa) assay by the customer, resulting low.The customer performed repeat psa testing on the original patient sample (30-mar-2021), run on the same atellica im instrument and reagent lot, resulting low.The lower psa result was reported as the corrected result to the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, high atellica im prostate-specific antigen (psa) result.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2021-00233 initial report on 26-apr-2021 for a discordant, falsely elevated non-reproducible atellica im prostate-specific antigen (psa) result on a prostatectomy patient when tested with reagent lot 311.25-jun-2021: additional information: additional information: siemens has completed the investigation.Assay calibration and quality control (qc) data were not provided.Siemens reviewed the system auto check files and noted possible system vacuum issues, however, the non-reproducible patient result could not be attributed to the possible vacuum issues.A review of the complaint handling database found no other similar escalations with atellica im psa reagent lot 311 and this appears to be an isolated or sample specific issue.The potential cause of the initial non-reproducible elevated psa result is unknown, however pre-analytical factors or sample handling cannot be ruled out.Preanalytical variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.The atellica im psa reagent lot 311 is performing as intended and a product performance issue has not been identified.The customer is operational.The assay is performing within specifications.No further evaluation of the device is required.In section h6, the investigation findings code and the investigation conclusion code were revised.

• Brand Name: ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA)
• Common Device Name: TOTAL PROSTATE SPECIFIC ANTIGEN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11729072
• Report Number: 1219913-2021-00233
• Device Sequence Number: 3830940
• Product Code: MTF
• UDI-Device Identifier: 00630414599809
• UDI-Public: 00630414599809
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P950021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995662
• Device Lot Number: 311
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR