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

Model Number N/A

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

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 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.

• Brand Name: ADVIA CENTAUR AFP
• Type of Device: 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: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18940920
• MDR Text Key: 338735320
• Report Number: 1219913-2024-00186
• Device Sequence Number: 1
• Product Code: LOJ
• UDI-Device Identifier: 00630414177328
• UDI-Public: 00630414177328
• Combination Product (y/n): N
• PMA/PMN Number: K020806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/20/2024
• Date Device Manufactured: 10/05/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1