MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP HEPATITIS B SURFACE ANTIGEN (HBS); HEPATITIS B SURFACE ANTIGEN IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

The customer observed a negative result from a patient sample with the advia centaur cp hbsag (hbs) assay from (b)(6) 2021.This result was reported to the physician who did not question the result.The customer also observed false negative results from this same patient with the advia centaur cp hbs assay on comparison with initial reactive results from the same sample when tested on (b)(6) 2022.The negative results were reported to the physician who did not question the results.The confirmed positive results were considered the correct result and were sent out as corrected results.There were no reports that treatment was altered or postponed or adverse health consequences due to the discordant false negative advia centaur cp hbs results.

Manufacturer Narrative

A us based customer observed negative result from a sample with advia centaur cp hepatitis b surface antigen (hbs) assay.Negative (actual values) were not provided and lot information was not provided for the sample tested on (b)(6) 2021.Siemens investigated for the information provided for the sample from (b)(6) 2022.The sample was drawn from a dialysis patient that recovered repeat reactive (1.10, 1.08, 1.21 index) on advia centaur cp (instrument id - 638533) with advia centaur hbsag kit lot 211 and confirmed (100.88% neutralization) with the advia centaur cp hbsag confirmatory (conf) assay.The sample was tested on a different advia centaur cp (536406) it was initial reactive (1.03 index) but repeats were nonreactive (0.88 and 0.89 index) however it was confirmed (120.5% neutralization) with the advia centaur cp conf assay.Customer indicated both levels of biorad qc, negative and positive, were in range on both systems.The customer declined service as both advia centaur cps have all qc in range for all assays.The sample was sent to their reference lab which used advia centaur (xp or xpt) and the result was reactive and confirmed.The customer was not able to provide a list of medications/supplements the patient was taking.There is no sample left to investigate.The sensitivity section of the advia centaur cp hbsag instructions for use (ifu) (10629974 revision g) lists the "95% confidence interval (ci) for sensitivity as 97.60% - 100.00%" so a certain number of false negatives are expected for this assay.One false negative result does not indicate a product problem with advia centaur cp hbsag.A review of internal data indicates advia centaur cp hbsag is performing as intended.The cause of the intermittent false negative result seen by the customer with this one sample when using advia centaur cp hbsag could not be determined but siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Based on the investigation, no product problem was identified.No further evaluation of the device is required.Mdr 1219913-2022-000053 was filed for the same event.

• Brand Name: ADVIA CENTAUR CP HEPATITIS B SURFACE ANTIGEN (HBS)
• Type of Device: HEPATITIS B SURFACE ANTIGEN IMMUNOASSAY
• 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: 13514831
• MDR Text Key: 289465707
• Report Number: 1219913-2022-00056
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1