MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP ALPHA-FETOPROTEIN (AFP) ASSAY; KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

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	12/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer from outside the united states reports observation of a discordant elevated alpha-fetoprotein (afp) result was obtained on one patient sample when processed on an advia centaur cp instrument.The initial issue was reported as advia centaur alpha-fetoprotein (afp) isolated false initial high result.Patient was run on december 8th and initially reported out at 481.5 ng/ml but repeated on same sample after result was questioned and result was 2.0ng/ml.All other test results on that sample were normal.A second sample was drawn to confirm the normal result of 2.0 ng/ml.Siemens investigation included an assessment of reagent, instrument, and sample data.Reagent issues were ruled out based on review of quality control (qc) which showed recovery within acceptable ranges and no issues were reported with other patient samples.Assessment of instrument performance included a review of internal in-house data.Based on the available information, the cause of the discordant result is consistent with preanalytical variables.Return of the patient sample for further investigation is not warranted because discordant result was not reproducible.The customer is operational.
Event or Problem Description
The customer reported a discordant elevated alpha-fetoprotein (afp, lot 276) result on one patient sample when processed on an advia centaur cp instrument (s/n: (b)(6).The initial elevated result was reported to the physician and was questioned.The same sample was retested again on the same instrument and obtained a lower result.A new sample was also drawn from the same patient and tested on the same instrument, obtained a lower result that matched the previously retested result.The lower result was considered correct and issued on the corrected report.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated afp result.

• Brand Name: ADVIA CENTAUR CP ALPHA-FETOPROTEIN (AFP) ASSAY
• Common Device Name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• 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: 18552820
• Report Number: 1219913-2024-00011
• Device Sequence Number: 20732179
• Product Code: LOK
• UDI-Device Identifier: 00630414177328
• UDI-Public: 00630414177328
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Report Date (Section B): 01/22/2024

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: 10/06/2024
• Device Model Number: N/A
• Device Catalogue Number: 10309979
• Device Lot Number: 57972276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 01/22/2024
• Date Device Manufactured: 07/06/2023
• 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