MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR HBSAG QUALITY CONTROL MATERIAL; HEPATITIS B SURFACE ANTIGEN QUALITY CONTROL

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	12/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The operator from the united states was not wearing the recommended eye protection while handling the advia centaur (b)(6) controls and may have been exposed to biohazardous material.As stated in the warnings section of the advia centaur (b)(6) quality control instructions for use (ifu) (10994410_en revision d, 2019-08):" caution! potential biohazard: the controls 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.Use eye protection and gloves when handling this product; wash hands after handling." the customer was provided a copy of the advia centaur (b)(6) quality control ifu and the advia centaur (b)(6) quality control safety data sheet (sds).The analyzer is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer contacted a customer care center and reported that while discarding uncapped aliquots of siemens advia centaur (b)(6) quality control material the operator was splashed in the eye.The operator was wearing prescription eyeglasses, not laboratory safety glasses and the liquid splashed under her glasses.The operator rinsed her eye with an eye wash.There was no pain, redness or apparent injury to the eye.There are no known reports of patient intervention or adverse health consequences due to this incident.

• Brand Name: ADVIA CENTAUR HBSAG QUALITY CONTROL MATERIAL
• Common Device Name: HEPATITIS B SURFACE ANTIGEN QUALITY CONTROL
• 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: 13060964
• Report Number: 1219913-2021-00509
• Device Sequence Number: 16520635
• Product Code: LOM
• UDI-Device Identifier: 00630414472881
• UDI-Public: 00630414472881
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P30049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2021

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: 09/10/2022
• Device Model Number: N/A
• Device Catalogue Number: 10309059
• Device Lot Number: 652662532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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