MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA); 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	12/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of an elevated atellica im prostate-specific antigen (psa) result which was discordant relative to clinical expectation and repeat testing.An initial elevated psa result was obtained for a post-prostatectomy patient, and not reported to the physician.The sample was tested two more times, using the same method and instrument, and both repeat tests were lower (near zero), as expected.The result from the third test was accepted as correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im prostate-specific antigen (psa) result which was discordant relative to clinical expectation and repeat testing.There were no issues noted with either calibration or quality control (qc) data.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens healthcare diagnostics is investigating.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im prostate-specific antigen (psa) result which was discordant relative to clinical expectation and duplicate repeat testing.No issues were identified with quality control or calibration for the assay, but associated data were not provided for review.Investigation included assessment of available reagent, instrument, and sample data.Reagent issues were ruled out as reproducible results meeting expectation were produced upon repeat testing using the same reagent pack.Instrument log data show no evidence of any hardware issues affecting delivery of any psa reagents, and no evidence of any sample probe issues during aspiration or dispense of the affected sample.Return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.Based on the available information, the root cause cannot be definitively determined, but the issue appears to be an isolated case, and preanalytical variables (sample-quality issues) cannot be ruled out.No product problem was identified.The customer is operational, and no further action is required.

• Brand Name: ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA)
• Common Device Name: PROSTATE-SPECIFIC ANTIGEN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 18472338
• Report Number: 1219913-2024-00004
• Device Sequence Number: 12364150
• Product Code: MTF
• UDI-Device Identifier: 00630414599809
• UDI-Public: 00630414599809
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P950021-S016
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: 05/16/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995662
• Device Lot Number: 331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male