MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBS II; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 08498598190

Device Problems False Positive Result (1227); Non Reproducible Results (4029)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

The cobas 6000 e601 module serial number was (b)(6).The field service engineer cleaned the reagent probe, checked the choke, adjusted the water-pressure gauge, adjusted the gear pump, performed a check test, washed the reagent probe, primed the reagent, and purged the pipetter air.Qc was performed and was acceptable.The investigation determined the issue was resolved after the service actions.

Event Description

There was an allegation of questionable anti-hbs g2 results from the cobas 6000 e601 module for patient samples and qc material.The samples were tested using the elecsys hbsag ii assay and anti-hbs g2 assay simultaneously.Sample 1 hbsagii result was 0.462 coi (non-reactive).The initial ahbs-2 result was 15.22 u/l (reactive) and the repeat result was <2.00 u/l (non-reactive).Sample 2 hbsagii result was 0.494 coi (non-reactive).The initial ahbs-2 result was 14.67 u/l (reactive) and the repeat result was <2.00 u/l (non-reactive).Sample 3 hbsagii result was 0.523 coi (non-reactive).The initial ahbs-2 result was 11.25 u/l (reactive) and the repeat result was <2.00 u/l (non-reactive).

• Brand Name: ELECSYS ANTI-HBS II
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18968514
• MDR Text Key: 338552476
• Report Number: 1823260-2024-00885
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): Y
• Reporter Country Code: TH
• PMA/PMN Number: P010054
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08498598190
• Device Lot Number: 71433300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1