MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) ASSAY; AHBS IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report (b)(6) advia centaur xpt (b)(6) results from the same patient.A customer service engineer (cse) was dispatched to the site for system inspection.The patient sample was rerun post service and similar advia centaur xpt (b)(6) results were obtained.Siemens is investigating.Sample rerun results post service: (b)(6).
Event or Problem Description
(b)(6) advia centaur xpt (b)(6) results were obtained by the customer on the same patient and considered discordant compared to a (b)(6) alternate (b)(6) test method result.The nonreactive alternate (b)(6) test method result was reported to the physician(s) as the correct result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the (b)(6) advia centaur xpt (b)(6) results.
Additional Manufacturer Narrative
Mdr 1219913-2020-00182, was filed on (b)(6) 2020, for discordant, false reactive (positive) advia centaur xpt anti-hbs2 (ahbs2) results from the same patient.(b)(6) 2020 - additional information: siemens was informed of patient and lot number information that was not previously provided.B7.The patient has an infectious disease and was tested before surgery.The customer was not able to provide any additional patient information.D4.Lot # 118; expiration date 22-mar-2021.H4.Device manufacture date: 22-mar-2019.The patient sample is not available for further testing.The instructions for use (ifu) under the clinical sensitivity and specificity section lists the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88%, thus false positive results can be expected for this assay.Based on the information provided, and a review of internal data, the one false positive patient sample does not indicate a product problem with advia centaur xpt ahbs2 reagent lot 118.The potential cause for the the false positive result observed by the customer is unknown, however pre-analytical factors, a sample issue, or normal assay performance cannot be ruled out.Incident investigation conclusion is pending customer support feedback.Section h6 result code was updated to reflect the additional information.
Additional Manufacturer Narrative
Mdr 1219913-2020-00182 was filed on 23-jul-2020 for false reactive (positive) advia centaur xpt anti-hbs2 (ahbs2) results obtained on the same patient.Mdr 1219913-2020-00182 supplemental report 1 was filed on 21-aug-2020 for additional information.25-aug-2020 additional information: siemens has reviewed the event data and has concluded the incident investigation.A review of internal data indicates advia centaur xpt ahbs2 lot 118 is performing as intended and no product problem was identified.Siemens has received customer support feedback and the customer is operational.In summary, the potential cause for the false positive result observed by the customer is unknown, however pre-analytical factors, a sample issue, or normal assay performance cannot be ruled out.The assay is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) ASSAY
• Common Device Name: AHBS IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10317319
• Report Number: 1219913-2020-00182
• Device Sequence Number: 3623613
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2020

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: 03/22/2021
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 118
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/30/2020; 08/25/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/21/2020; 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1