MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR AFP; KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

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	02/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the us (ous) customer contacted the siemens customer care center (ccc) to report an observation of a discordant (low) advia centaur afp result that was considered discordant relative to the higher retest result.The customer states that all procedures and conditions concerning storage, reconstitution, use and the pre-analytical sample preparation phase were followed.The interpretation of results section of the instructions for use (ifu) states, "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.
Event or Problem Description
A customer obtained a low initial result with the advia centaur afp assay (lot 280) on an advia centaur xpt instrument.The initial result was considered discordant relative to the higher retest result obtained when the same sample was retested on the same instrument on a different day.The initial result was reported and questioned.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the discordant low afp result.
Additional Manufacturer Narrative
Siemens investigated a customer report of a discordant low advia centaur afp (lot: 280) patient result (sid#: (b)(6) that was higher upon retesting.The initial result obtained was >1000ng/ml, but upon dilution, results were negative (10x result: <0.0ng/ml, 20x result: <0.0ng/ml, 100x result: 5.1ng/ml).The final correct result was 3026.1 ng/ml.The instructions for use (ifu), which states, "patient samples with high afp levels can cause a paradoxical decrease in the rlus (high-dose hook effect)." based on the available information, the cause of the sid#: (b)(6) discordant results may be attributed to hook effect as all diluted values obtained negative results.A product malfunction was not identified.The customer is operational.Siemens filed mdr 1219913-2024-00188 on 20-mar-2024.In section h6 of this report, the investigation finding and conclusion codes were updated based on the investigation results.

• Brand Name: ADVIA CENTAUR AFP
• Common Device Name: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
• 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: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18943026
• Report Number: 1219913-2024-00188
• Device Sequence Number: 8232140
• Product Code: LOJ
• UDI-Device Identifier: 00630414177328
• UDI-Public: 00630414177328
• Combination Product (Y/N): N
• PMA/510(K) Number: K020806
• 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): 02/18/2025

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: 01/05/2025
• Device Model Number: N/A
• Device Catalogue Number: 10309979
• Device Lot Number: 280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 02/18/2025
• Date Device Manufactured: 10/05/2023
• 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: Unknown