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

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	03/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of united states (ous) customer reported observation of discordant elevated alpha-fetoprotein (afp) result obtained on one patient sample when processed on an advia centaur xp analyzer.Siemens is evaluating the event.
Event or Problem Description
The customer reports an observation of a discordant elevated alpha-fetoprotein (afp) result for one patient sample when processed on an advia centaur xp analyzer.The initial elevated result was reported and questioned by the physician(s).The same sample was reprocessed on the same analyzer and produced a lower result.A corrected report was issued to the physician(s) based on the repeat testing.For troubleshooting purposes, a new sample was drawn from the same patient, tested on the same analyzer and also produced a lower result that the initial test.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Mdr 1219913-2024-00289 was initially filed on 12-apr-2024.Additional information (23-apr-2024): siemens healthcare diagnostics has concluded the investigation of the event.A customer from outside the united states reported observation of an elevated advia centaur alpha-fetoprotein (afp) result which was discordant relative to repeat testing.Siemens evaluated the instrument data and the information provided by the customer.Quality control (qc) results were within expected ranges at the time of the observation, and no instrument errors were observed in association with the discordant result.Service was dispatched to the customer site, and the instrument¿s event log was reviewed.Other samples tested around the time of the discordant observation had generated signal errors due to abnormal response curves, although the sample in question did not.Close review of the instrument data showed that the signal curve for the discordant result was anomalous relative to that of the repeat test.Routine cleaning and instrument service were performed.The customer is operational, and has reported no further concerns with afp assay performance.Although a specific cause for the discordant result was not determined, no product problem was identified.Note: in section h6, codes for investigation findings and investigation conclusions were updated.

• Brand Name: ADVIA CENTAUR ALPHA FETOPROTEIN (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.; registration# 1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19099962
• Report Number: 1219913-2024-00289
• Device Sequence Number: 7705512
• Product Code: LOJ
• UDI-Device Identifier: 00630414177335
• UDI-Public: 00630414177335
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020806
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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: 10309980
• Device Lot Number: 276
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 89 YR
• Patient Sex: Female