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

Device Problem False Positive Result (1227)

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

Event Date 12/31/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event 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).

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
• Type of Device: 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
• MDR Text Key: 308761260
• Report Number: 1823260-2023-00326
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 04015630911110
• UDI-Public: 04015630911110
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P990012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/07/2023
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 04/10/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Male