MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HBSAG CONFIRMATORY TEST; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number	11820648122
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hbsag confirmatory test results for 4 patient samples on a cobas e 801 analytical unit.The customer suspects that the hbsag confirmatory results are false positive in relation to the anti-hepatitis b surface antibody and anti-hepatitis b core antibody results.They were questioning whether this pattern of results was possible.On (b)(6) 2022, patient b's sample was tested on line c and had two reactive hbsag test results.The first result was 2.04 coi and the second result after re-centrifugation was 1.82 coi.The hbsag confirmatory test was performed and the result was reactive with a quantitative result of 0.436.The anti-hepatitis b surface antibody result was non-reactive with a quantitative result of <2 miu/ml.The anti-hepatitis b core antibody result was non-reactive with a quantitative result of 2.02 coi.Patient c's sample was tested on line c and had three reactive hbsag test results.The first result was 1.5 coi, the second result was 1.56 coi, and the third result after re-centrifugation was 1.5 coi.The hbsag confirmatory test was performed and the result was reactive with a quantitative result of 0.474.The anti-hepatitis b surface antibody result was non-reactive with a quantitative result of 8 miu/ml.The anti-hepatitis b core antibody result was non-reactive with a quantitative result of 2.06 coi.Patient d's sample was tested on line c and had three reactive hbsag test results.The first result was 2 coi, the second result was 2.03 coi, and the third result after re-centrifugation was 1.97 coi.The hbsag confirmatory test was performed and the result was reactive with a quantitative result of 0.42.The anti-hepatitis b surface antibody result was non-reactive with a quantitative result of 4 miu/ml.The anti-hepatitis b core antibody result was non-reactive with a quantitative result of 2.23 coi.On (b)(6) 2023, patient e's sample was tested on group line 1 and had two reactive hbsag test results.The first result was 1.16 coi and the second result was 1.21 coi.The hbsag confirmatory test was performed and the result was reactive with a quantitative result of 0.418.The anti-hepatitis b surface antibody result was non-reactive with a quantitative result of <2 miu/ml.The anti-hepatitis b core antibody result was non-reactive with a quantitative result of 2.20 coi.The hbsag confirmatory units of measure were requested but not provided.No questionable results were reported outside of the laboratory.The analyzer serial number is (b)(4).
Additional Manufacturer Narrative
Based on the calibration and qc data provided, a general reagent issue could be excluded.It was determined that the root cause of the event is consistent with contamination and pre-analytical sample handling issues.

• Brand Name: ELECSYS HBSAG CONFIRMATORY TEST
• Common Device Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16285810
• Report Number: 1823260-2023-00326
• Device Sequence Number: 6701433
• Product Code: LOM
• UDI-Device Identifier: 04015630911110
• UDI-Public: 04015630911110
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P990012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 04/10/2023

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: 02/29/2024
• Device Catalogue Number: 11820648122
• Device Lot Number: 644791
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Male