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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

A siemens' customer service engineer (cse) went on site and ran background tests for dry, wet wash and water.All results fell within acceptable ranges.The customer told the cse that the sample was sent for confirmation testing on a different analyzer and the result was 1.4 ng/ml.The cse noted dark material adhered to the side of the reagent readypack.The cse reviewed the event log around the time of the discrepant result and no events were noted.No issues noted upon review of calibration data.No problems found when a full system check was performed.Probe alignments were verified along with sample tip to cuvette alignment and centering.The sample syringe was lubricated.Five replicates of the patient sample were run and all results were less than 1.3 ng/ml.The instrument is performing as expected.No further investigation is planned.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 Description

Customer observed an initial elevated advia centaur xp afp result compared to duplicate, repeat testing of the sample.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp afp result.

Manufacturer Narrative

Mdr 1219913-2018-00226 was filed on september 11, 2018 reporting an initial elevated advia centaur xp afp result compared to duplicate, repeat testing of the of the sample.September 13, 2018 - additional information: the customer sent the sample to a sister lab where it was tested on the immulite 2000 and the result was 1.4 ng/ml which was similar to the repeat testing of the sample on the advia centaur xp.The advia centaur xp afp assay is performing as intended.Considering that the issue was related to a single patient sample, pre-analytical variables possibly contributed to the discordant result.

• Brand Name: ADVIA CENTAUR XP AFP ASSAY
• Type of Device: AFP IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOTICS, INC; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7863683
• MDR Text Key: 119796244
• Report Number: 1219913-2018-00226
• Device Sequence Number: 1
• Product Code: LOJ
• UDI-Device Identifier: 00630414177328
• UDI-Public: 00630414177328
• Combination Product (y/n): N
• PMA/PMN Number: K020806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2019
• Device Model Number: N/A
• Device Catalogue Number: 10309979
• Device Lot Number: 78173196
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1