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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report a discordant, a low atellica im prostate-specific antigen (psa) result obtained on a patient sample.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." mdr 1219913-2021-00224 was filed for the same patient (sid (b)(6)) and for the same event.
Event or Problem Description
A discordant, low atellica im prostate-specific antigen (psa) result was obtained on a patient sample and questioned by the physician(s).The sample was repeated, resulting low.Another blood draw was obtained on the patient.The new sample was run on the same atellica im instrument neat and with dilution, resulting higher.The higher psa dilution 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, low atellica im prostate-specific antigen (psa) result.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2021-00223 initial report on 13-apr-2021 for a discordant, low atellica im prostate-specific antigen (psa) result obtained on a patient sample.On 23-apr-2021: additional information: b6 - the acronym for "psal" reference in b6 is the atellica im free prostate-specific antigen (fpsa) assay.D8 - siemens was informed that the device was not serviced by a third party.Siemens has completed the investigation.The customer reported a patient sample that produced a result of 26.53 ng/ml when run undiluted on their atellica im system with prostate-specific antigen (psa) reagent lot 309.A new sample was drawn at a later date and had similar psa results.The sample was diluted 1:10 and 1:50 on the same system and the results were >1000 ng/ml and >5000 ng/ml respectively.The elevated psa results that were obtained upon dilutions indicate a high dose hook effect.The requested assay calibration and quality control (qc) results were not provided.Based on the available information, the atellica im prostate specific antigen (psa) assay with reagent lot 309 is performing as intended.A product problem was not identified and the customer is operational.In section h6, the investigation findings code and the investigation conclusion code were revised.Mdr 1219913-2021-00224 supplemental report 1 was filed for the same event.

• 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: 11657862
• Report Number: 1219913-2021-00223
• Device Sequence Number: 3511920
• 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): N
• 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): 05/18/2021

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: 07/23/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995662
• Device Lot Number: 309
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1