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	04/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report a discordant, (b)(6) advia centaur xpt anti-hbs2 (ahbs2) patient result.Quality control (qc) results were within acceptable ranges when the event occurred.The customer performed a repeatability system check on 06-aug-2020 that was acceptable.Siemens is investigating.
Event or Problem Description
A (b)(6) advia centaur xpt anti-hbs2 (ahbs2) result was obtained by the customer and reported to the physician(s).The (b)(6) result was considered discordant compared to a repeat (b)(6) anti-hbs2 result.The customer performed repeat testing on the samples from this patient and the results were (b)(6).The (b)(6) anti-hbs2 result was reported to the physician(s) as the corrected result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, (b)(6) advia centaur xpt anti-hbs2 (ahbs2) result.
Additional Manufacturer Narrative
Mdr 1219913-2020-00217 was filed on 19-aug-2020 for a false positive advia centaur xpt anti-hbs2 (ahbs2) result.28-aug-2020 additional information: siemens was made aware that the patient was a pregnant female, with a specific pathology of pregnancy cytolysis.Siemens continues to investigate the incident.In section h6, the health effect - clinical code, clinical impact code and the component code were added.
Additional Manufacturer Narrative
Mdr 1219913-2020-00217 was filed on 19-aug-2020 for a false positive advia centaur xpt anti-hbs2 (ahbs2) result and mdr 1219913-2020-00217 supplemental report 1 was filed on 12-oct-2020 for additional information.19-oct-2020: additional information: siemens has concluded the investigation.The customer had a sample from a patient with pregnancy cytolysis that recovered reactive (60.21 miu/ml) with advia centaur xpt anti-hbs2 (ahbs2) reagent lot 122.A second sample from the same patient drawn 3 months later recovered nonreactive.When the original sample was retested it recovered nonreactive with the advia centaur xpt ahbs2 reagent lot 122.The sample was also hbsag ii nonreactive and hbct nonreactive.A review of internal data indicates advia centaur xpt ahbs2 reagent lot 122 is performing as intended.The cause of the non-repeatable false positive result seen by the customer with this one sample when using advia centaur xpt ahbs2 reagent lot 122 is unknown, however pre-analytical factors or a sample issue cannot be ruled out.Based on the information provided, a product problem was not identified.The customer is operational.The assay is performing within specifications.No further evaluation of the device is required.In section h6, the investigation finding, and investigation conclusion codes were updated.

• 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: 10424844
• Report Number: 1219913-2020-00217
• Device Sequence Number: 2508678
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/12/2020

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: 01/29/2021
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 122
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/28/2020; 10/19/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 10/12/2020; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR