MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP AFP ASSAY; AFP IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens field service engineer (fse) was sent to the customer site for system inspection.The fse verified good wash block function.The fse made adjustments to the reagent probe 1 calibration.The customer replaced the afp reagent and ran all quality control (qc).The qc passed.The customer ran afp x5 on 4 patients.Precision is good.The customer confirmed afp is functioning properly on the analyzer.The customer had a sample that recovered 1.9 ng/ml when originally tested with advia centaur xp alpha-fetoprotein (afp) lot 193 but 3.0 ng/ml when retested.Two other samples showed similar differences.Siemens does not have any precision claims for the advia centaur xp afp assay with samples < 16.5 ng/ml.The values for the samples are well within the normal range (0 - 8.0 ng/ml) listed in the advia centaur xp afp instructions for use (ifu) so there is no change in clinical interpretation.The cause of the difference in the values cannot be determined but there is no indication it is abnormal performance.Based on the available information advia centaur xp alpha-fetoprotein (afp) lot 193 is performing as intended.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
A low advia centaur xp afp result was obtained for a patient sample.The customer repeats any sample with a result less than three.The patient sample was repeated and the result was higher.The initial result was reported to the physician and was not questioned.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant afp result.

• Brand Name: ADVIA CENTAUR XP AFP ASSAY
• Common Device Name: AFP IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7568996
• Report Number: 1219913-2018-00163
• Device Sequence Number: 13950182
• Product Code: LOJ
• UDI-Device Identifier: 00630414177335
• UDI-Public: 00630414177335
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K020806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2018

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: 11/17/2018
• Device Model Number: N/A
• Device Catalogue Number: 10309980
• Device Lot Number: 48772193
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1