MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR ANTI-HEPATITIS B SURFACE ANTIGEN 2; ADVIA CENTAUR AHBS2

Model Number	10286268
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states customer observed an elevated advia centaur xpt anti-hepatitis b surface antigen (ahbs2) result from a sample compared to the repeat result.Customer utilized vacuette serum separator tube (sst) tubes for serum collection and centrifuged for 7 minutes 2400 x gravitational force (g).Instructions for use (ifu) states the following: the clinical sensitivity and specificity section of the instructions for use provides an initial relative specificity of 99.8% (513/514 samples); 95% ci = 98.92 - 100%.Siemens is investigating.
Event or Problem Description
Customer observed an elevated advia centaur xpt anti-hepatitis b surface antigen 2 (ahbs2) result for a patient sample compared to the repeat result.The result was not reported to the physician.There were no reports that treatment was altered or prescribed or adverse health consequences due to the discordant elevated advia centaur ahbs2 result.
Additional Manufacturer Narrative
The initial mdr 1219913-2022-00092 was filed on march 25, 2022.Correction: in section b3, the date of event was initially stated as 10-dec-2021, however, the customer confirmed that the actual date of the event was 13-dec-2021.Section b3 was modified to reflect the correct date.In section b6, the initial mdr indicated that the initial discordant result and the repeat results occurred on 10-dec-2021.The customer clarified that the discordant result and the repeat results were tested on different days.Additional information - april 11, 2022: an outside the united states customer observed an elevated advia centaur xpt anti-hepatitis b surface antigen (ahbs2) result (21 iu/l; reactive) from a sample compared to the repeat results (<3.1 iu/l; 3.71 iu/l nonreactive) after recentrifugation of the sample.The sample was also hbsag reactive.The reactive result that was nonreactive after recentrifugation was likely due to particulate matter in the sample (e.G.Fibrin), not cross reactants or interferents.The customer was not able to provide the patient's medical status or a list of medications/supplements the patient was taking.The sample was drawn in a greiner vacuette serum separator tube, allowed to clot for at least 30 minutes, and centrifuged for 7 minutes at 2400x gravitational force (g) in a swing out rotor centrifuge.Greiner recommends allowing vacuette serum separator tubes to clot for 30 minutes and centrifuging vacuette serum separator tubes for 10 - 15 minutes.While the customer is meeting the 30 minute clotting requirement, if the patients are taking anticoagulant therapy the samples may require additional time to clot.Insufficient centrifugation may result in the presence of fibrin which could interfere with the advia centaur xpt ahbs2 assay.A review of internal data indicates advia centaur xpt ahbs2 kit lot 148 is performing as intended.The cause of the reactive result seen by the customer with this one sample using advia centaur xpt ahbs2 kit lot 148 could not be determined but siemens cannot rule out pre-analytical factors or a sample issue.Based on the investigation, no product problem was identified.The customer is operational.No further action is needed.In section h6, investigation findings and investigation conclusion codes were updated based on the investigation results.

• Brand Name: ADVIA CENTAUR ANTI-HEPATITIS B SURFACE ANTIGEN 2
• Common Device Name: ADVIA CENTAUR AHBS2
• 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: eiman sulieman ; 333 coney street; walpole, MA 02032 ; 7372808688
• MDR Report Key: 13901582
• Report Number: 1219913-2022-00092
• Device Sequence Number: 4240613
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P100039
• 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,Followup
• Report Date (Section B): 05/04/2022

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: 04/20/2023
• Device Model Number: 10286268
• Device Catalogue Number: 10286268
• Device Lot Number: 148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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