MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC ADVIA CENTAUR XP TOTAL HCG

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

This issue only affected this patient sample.Service was sent on site.The incubation ring dispense ports were cleaned of debris.Visual protocols were performed.All probe alignments were verified as well as the acid and base dispense volumes and pinch valve operation.Dry, wetwater and wetwash1 testing was performed.All results were good.While exact root cause of the initially high result cannot be determined, dried serum protein build up around the sample dispense entry port cannot be ruled out as the cause.Following service, customer is reporting controls and patients for thcg.A system non-conformance has not been identified.System is now operational.No further action 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 observed an elevated advia centaur xp total hcg (thcg) result that was not reproducible upon repeat testing and error messages were observed upon dilution of the sample.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp thcg result.

• Brand Name: ADVIA CENTAUR XP TOTAL HCG
• Type of Device: TOTAL HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, 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: 7227386
• MDR Text Key: 98974470
• Report Number: 1219913-2018-00010
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/30/2018

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: 05/10/2018
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 14688294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1