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
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the falsely elevated advia centaur xp alpha-fetoprotein (afp) patient result is unknown.The customer's assay calibration and quality controls (qc) were acceptable.Siemens is investigating the event.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.".
Event or Problem Description
A falsely elevated advia centaur xp alpha-fetoprotein (afp) result was observed on a patient sample, and the result did not correspond to a previous lower result.The customer performed repeat afp testing on the same sample and instrument, and the results were lower.The elevated afp result was not reported to the physician.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp afp result.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2018-00261 on 10/22/2018 for a falsely elevated advia centaur xp alpha-fetoprotein (afp) patient result, and is investigating the event.10/23/2018 - correction: the date of expiration for the year in operator of device was a typographical error.Operator of device: expiration date: 5/15/2019.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2018-00262 on 10/22/2018 for a falsely elevated advia centaur xp alpha-fetoprotein (afp) patient result, and mdr 1219913-2018-00262 supplemental report 1 on 10/29/2018 for a correction.11/13/2018 - h10 correction: there was a typographical error on mdr 1219913-2018-00262 - supplemental report 1.The reference to mdr 1219913-2018-00261 supplemental report 1 was incorrect.Siemens filed mdr 1219913-2018-262 supplemental report 1 on 10/22/2018.11/13/2018: additional information: the customer has informed siemens if patient results do not match, or for results above the cutoff, the sample clotting time is increased to 30 minutes, and the centrifugation time is 10 minutes.11/14/2018: additional information: siemens has completed the incident investigation.The customer did not report discordant results with quality control or assay calibrations, and has increased the clotting time and spin time for sample preparation.Other marker(s) ca19-9 was run on the same sample however were not repeated.Based on the information provided, the cause for the discordant advia centaur xp alpha-fetoprotein (afp) result is unknown.The customer has made pre-analytical changes in sampling handling and preparation.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 specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP AFP ASSAY
• Common Device Name: 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: 7993084
• Report Number: 1219913-2018-00262
• Device Sequence Number: 1774441
• Product Code: LOK
• UDI-Device Identifier: 00630414177328
• UDI-Public: 00630414177328
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P930036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2018

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: 05/15/2018
• Device Model Number: N/A
• Device Catalogue Number: 10309979
• Device Lot Number: 041199
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 10/23/2018; 11/13/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 10/29/2018; 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1