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

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	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the repeat testing of the sample on the initial instrument resulted as <1 ng/ml, preanalytical variables cannot be ruled out for this sample.At this time, the issue appears isolated to one sample.No further evaluation of the device is required.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
Customer observed an elevated result for advia centaur xp afp that was lower upon repeat testing.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp afp result.
Additional Manufacturer Narrative
Mdr 1219913-2018-00225 was filed on september 5, 2018 reporting that the customer observed an elevated result for advia centaur xp afp that was lower upon repeat testing.On september 6, 2018 - additional information: after the initial filing, a service report was provided and reviewed.A customer service engineer (cse) performed an evaluation of the affected system and during the course of troubleshooting replaced several parts related to the functionality of the afp assay.The following parts were replaced: sample syringe, sample syringe tubing, reagent probe 1,and reagent probe 1 diluter.All of the parts replaced affect the functionality of the afp assay so it is inconclusive to determine which singular item could have potentially contributed to the patient sample discrepant result.The cse made no observations that any of the parts had actually failed.Considering that there was only 1 patient sample affected it should not be ruled out that preanalytical variables contributed to the patient sample discrepant result.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP AFP ASSAY
• Common Device Name: AFP IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOTICS, INC; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7848012
• Report Number: 1219913-2018-00225
• Device Sequence Number: 1940657
• Product Code: LOJ
• UDI-Device Identifier: 00630414177328
• UDI-Public: 00630414177328
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 09/25/2018

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: 01/25/2019
• Device Model Number: N/A
• Device Catalogue Number: 10309979
• Device Lot Number: 99956196
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1