MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR ANTI-HBS2 ASSAY; AHBS IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of reproducibly positive (reactive) advia centaur xp anti-hbs2 (ahbs2) results for one patient which were discordant relative to alternate test results and clinical indications.Repeat testing using another advia centaur xp analyzer produced a similar (reactive) result.The sample was sent to an external lab, where it was tested using an alternate platform, producing a negative result.The negative results were accepted as correct and reported to the physician.There are no allegations of patient harm, changes in treatment, or delay of diagnosis in association with the observed result discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of reproducibly positive (reactive) advia centaur xp anti-hbs2 (ahbs2) results for one patient which were discordant relative to alternate test results and clinical indications.Reactive advia centaur ahbs2 results were discordant relative to other nonreactive advia centaur hepatitis b marker test results for the patient.The negative results were better aligned with the clinical picture for the patient.Additional external-laboratory testing of the sample produced a negative result for hepatitis b antibody, which was accepted as correct.The assay's instructions for use (ifu) states the following, under limitations: "assay performance characteristics have not been established when the advia centaur anti-hbs2 assay is used in conjunction with other manufacturers' assay for specific hbv serological markers" siemens is investigating.Note: mdr 1219913-2022-00254 has been submitted for the same event.
Additional Manufacturer Narrative
Mdr 1219913-2022-00255 was initially filed on 2022-08-22.Additional information, 2022-08-30: siemens has concluded the investigation.A customer from outside the united states reported observation of reproducibly positive (reactive) advia centaur xp anti-hbs2 (ahbs2) results for one patient which were discordant relative to alternate test results and clinical indications.The customer did not provide any details regarding the medical/treatment history of the patient.It was noted that additional hepatitis testing had produced negative results, which were consistent with the patient's clinical picture.There was insufficient remaining sample volume to allow additional testing by siemens.Siemens cannot exclude pre-analytical factors or a sample interferent as potential causes for the observation.Quality control (qc) results for ahbs2 were within range on the date of the discordant observation.The clinical sensitivity and specificity section of the advia centaur xp/xpt anti-hbs2 instructions for use (ifu) states the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88%, so it is understood that a certain number of false positive results can be expected for this assay.A product performance issue has not been identified.The customer is operational; no further investigation is required.Notes 1) in section h6, the codes for investigation findings and investigation conclusion have been updated.2) mdr 1219913-2022-00254 supplemental 1 was submitted for the same event.

• Brand Name: ADVIA CENTAUR ANTI-HBS2 ASSAY
• Common Device Name: AHBS 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: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 15271872
• Report Number: 1219913-2022-00255
• Device Sequence Number: 6599717
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/19/2022

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 Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• 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 Age: 41 YR
• Patient Sex: Female