MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP INSTRUMENT

Model Number ADVIA CENTAUR XP INSTRUMENT

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

An outside the united states customer contacted siemens to report that a delay of approximately two hours in the reporting of one human chorionic gonadotropin (thcg) patient sample test result occurred with an advia centaur xp instrument.The operator indicated the sample was initially tested and found to be positive with a gold standard method and that this test result should be reported.It is unknown if this test result was obtained from the advia centaur xp instrument.It is unknown if this was the test result that was reported after the delay.A customer service engineer (cse) was dispatched to the customer site to inspect the instrument.The cse found that the cuvette loader was jammed.The cse cleared the cuvettes in the cuvette loader, cleaned and adjusted the cuvette pusher, and rebooted the analyzer.Quality control (qc) materials were run with acceptable results.The cause of the delay in reporting the test result was a cuvette jam.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.

Event Description

A delay of approximately two hours in the reporting of one human chorionic gonadotropin (thcg) patient sample test result occurred with an advia centaur xp instrument.There are no known reports of patient intervention or adverse health consequences due to the event.

• Brand Name: ADVIA CENTAUR XP INSTRUMENT
• Type of Device: ADVIA CENTAUR XP INSTRUMENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING; registration #: 8020888; chapel lane; swords, co, dublin, 10040 ; EI 10040
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 15184581
• MDR Text Key: 305243501
• Report Number: 2432235-2022-00223
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: 00630414573564
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K041133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP INSTRUMENT
• Device Catalogue Number: 10364455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female