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 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer went on site and did not identify any mechanical issues related to the event.Preventative maintenance was performed.Precision of calibration and qc was acceptable and no fliers were observed.The high level control was out of the 2sd range by less than 0.5 sd and does not represent a flier.The level 1 control was within range on the day of the elevated patient result.The level 1 control is closer in value to the patient sample value and does not indicate an issue with the calibration.Root cause was not identified.Preanalytical variables cannot be ruled out.The issue is isolated to one sample.The system is operational and no further action or investigation 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 Description

Customer reported an elevated advia centaur xp alpha-fetoprotein (afp) result.The physician questioned the result.The sample was repeated and the result was lower and aligned with previous results.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp afp 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 8000908
• MDR Text Key: 126238107
• Report Number: 1219913-2018-00265
• Device Sequence Number: 1
• Product Code: LOJ
• UDI-Device Identifier: 00063041477328
• UDI-Public: 0063041477328
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/24/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2019
• Device Model Number: N/A
• Device Catalogue Number: 10309979
• Device Lot Number: 09370199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1