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

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
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.A siemens application specialist was at the customer site previously, and observed an outlier when performing a precision check.A siemens customer service engineer (cse) checked the system, and no issues were observed.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.The customer performed repeat afp testing on the same sample, and instrument without additional sample centrifugation, 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 1219913-2018-00307 on 12/27/2018 for a falsely elevated advia centaur xp alpha-fetoprotein (afp) patient result.01/08/2019 - correction: the date of expiration for the year in d5 was a typographical error.Expiration date - 5/15/2019.01/08/2019 - additional information: siemens has completed the incident investigation.The customer's assay calibration and quality controls (qc) were acceptable at the time of the incident.A siemens customer service engineer (cse) checked the system, and no issues were observed, however the base pump and pinch valve tubing were replaced, and sealing of the wash probe.The sample is not available for further testing.Siemens has not identified other assay related complaints regarding root cause investigations.Reagent lot 041199 quality control kit release data was reviewed, and no abnormal high results were observed.The cause for the falsely elevated advia centaur xp alpha-fetoprotein (afp) patient result is unknown.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 TESTICULAR CANCER; KIT, TEST, ALPHA-FETOPROTEIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8199490
• Report Number: 1219913-2018-00307
• Device Sequence Number: 16675655
• Product Code: LOJ
• UDI-Device Identifier: 00630414177335
• UDI-Public: 00630414177335
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K020806
• 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
• Report Date (Section B): 01/11/2019

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: 10309980
• Device Lot Number: 041199
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1