MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR HIV 1/O/2 ENHANCED QUALITY CONTROL (EHIV QC); HIV QUALITY CONTROL MATERIAL

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
While handling the advia centaur hiv 1/o/2 enhanced positive quality control (ehiv qc), the customer was splashed in the eye.The customer was not wearing protective goggles or a face shield while handling the material.The customer washed his eyes with water.There are no reports of patient intervention or adverse consequences due to the splash.
Additional Manufacturer Narrative
The operator from outside the united states was not wearing the recommended eye protection while handling the advia centaur ehiv controls and was splashed in the eye with the positive control.The safety data sheet was provided to the customer.The warnings and precautions section of the advia centaur xp and advia centaur xpt systems ehiv instructions for use states: "caution potential biohazard some components of this product contain human source material.No known test method can offer complete assurance that products derived from human blood will not transmit infectious agents.All products manufactured using human source material should be handled as potentially infectious.Handle this product according to established good laboratory practices and universal precautions.The negative control has been assayed by fda-approved methods and found to be nonreactive for hepatitis b virus, antibody to hcv, and antibody to hiv-1/2.The positive controls, low calibrator and high calibrator have been assayed by fda-approved methods and found to be nonreactive for hepatitis b virus and antibody to hcv.The positive controls, low calibrator, and high calibrator contain human plasma that is reactive for antibody to hiv.The units were treated with a bpl-uv inactivation procedure,however, all products manufactured using human source material should be handled as potentially infectious." the warning section contains the following statement: "wear protective gloves/protective clothing/eye protection/face protection." advia centaur ehiv controls are not available in the united states, however, there is a similar product available in the united states under bp050030.

• Brand Name: ADVIA CENTAUR HIV 1/O/2 ENHANCED QUALITY CONTROL (EHIV QC)
• Common Device Name: HIV QUALITY CONTROL MATERIAL
• 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 ; 7818564812
• MDR Report Key: 16718173
• Report Number: 1219913-2023-00081
• Device Sequence Number: 7172049
• Product Code: MZF
• UDI-Device Identifier: 00630414509372
• UDI-Public: 00630414509372
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: REF H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 04/11/2023

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 Expiration Date: 04/29/2023
• Device Model Number: N/A
• Device Catalogue Number: 10309010
• Device Lot Number: 741771193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown