MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	10364455
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens to report that an operator of an advia centaur xp analyzer was splashed in the eye by a drop of control material.Siemens reviewed the available information and found that the advia centaur rubella control insert and advia centaur hbsag control inserts contain an appropriate warning for biohazard safety.It is unknown if the customer was following universal precautions or was wearing personal protective equipment (ppe) or eye protection while handling the control material.The cause of the eye splash is an unintentional use error.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
An operator of an advia centaur xp analyzer was splashed in the eye by a drop of control material.The operator was manually swirling the control material.The operator flushed his eye with saline and will seek follow treatment locally.The control material was for rubella or hepatitis b (hbsag).The customer is seeking a procedure for how to address a potential infection from the splash.There are no known reports of patient intervention or adverse health consequences due to the event beyond flushing the eye with saline.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane; swords, co.; dublin ; EI
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591
• MDR Report Key: 19920997
• Report Number: 2432235-2024-00171
• Device Sequence Number: 7218741
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: (01)00630414573564
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

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 Model Number: 10364455
• Device Catalogue Number: 10364455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/06/2024
• Date Device Manufactured: 07/05/2010
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown