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

Device Problem No Apparent Adverse Event (3189)

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

Event Date 12/11/2018

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 131943777
• Report Number: 1219913-2018-00307
• Device Sequence Number: 1
• Product Code: LOJ
• UDI-Device Identifier: 00630414177335
• UDI-Public: 00630414177335
• 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,u
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1