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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating the falsely elevated advia centaur xp alpha-fetoprotein (afp) patient result.The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." mdr 1219913-2018-00007 was filed for an initial result from the same patient, and mdr 1219913-2018-00009 was filed for an additional result from the same patient on a different advia centaur system.

Event Description

A falsely elevated advia centaur xp alpha-fetoprotein (afp) result was observed on a patient sample, and the reported result was questioned by the physician.The customer performed repeat afp testing on the same instrument, serial sample dilutions, ran the sample on another advia centaur system, and the results were elevated.The patient sample was tested on two alternate afp test methods that resulted lower.A corrected report was issued.There is no report of patient treatment prescribed or altered.There was no report of adverse health consequences due to the discordant advia centaur xp afp result.Mdr 1219913-2018-00007 was filed for an initial result on the same system, and mdr 1219913-2018-00009 was filed for repeat on a different advia centaur system.

Manufacturer Narrative

Siemens filed mdr 1219913-2018-00008 on 01/19/2018 for a falsely elevated advia centaur xp alpha-fetoprotein (afp) result on a patient sample.01/29/2018 - additional information: the cause for the falsely elevated advia centaur xp alpha-fetoprotein (afp) result is unknown, and may be attributed to an unknown interferent.When the customer diluted the sample 1:5, 1:10, 1:20, and 1:40, it diluted linearly, and the sample after correction for dilution, recovered ~10,000 ng/ml.The patient has no indication of a diagnosis of cancer, and a list of medications the patient is taking was not provided.The patient sample is not available for further investigation.Siemens is not aware of similar afp complaints with reagent lot 041188.No conclusion can be drawn.The instruction for use (ifu) under the intended use section states the following: "for in vitro diagnostic use in the quantitative determination of alpha-fetoprotein (afp) in the following: · human serum, as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the advia centaur®, advia centaur xp, and advia centaur xpt systems.The instructions for use under the warnings section states the following: "the advia centaur afp assay is not a screening test for cancer and must never be used as such.Do not interpret serum afp as absolute evidence of the presence of malignant disease." the instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instrument is performing within specification, no further evaluation of the device is required.Mdr 1219913-2018-00007 was filed for an initial result from the same patient, and mdr 1219913-2018-00009 was filed for an additional result from the same patient on a different advia centaur system.Mdr 1219913-2018-00007 supplemental report 1, and mdr 1219913-2018-00009 supplemental report 1 were filed for additional information.

• Brand Name: ADVIA CENTAUR XP AFP ASSAY
• Type of Device: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7208028
• MDR Text Key: 97988962
• Report Number: 1219913-2018-00008
• Device Sequence Number: 1
• Product Code: LOK
• UDI-Device Identifier: 00630414177328
• UDI-Public: 00630414177328
• Combination Product (y/n): N
• PMA/PMN Number: P930036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2018
• Device Model Number: N/A
• Device Catalogue Number: 10309979
• Device Lot Number: 041188
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR