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

Catalog Number 09014926190

Device Problems False Negative Result (1225); Insufficient Information (3190); Non Reproducible Results (4029)

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

Event Date 03/02/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the e801 analyzer is (b)(6).The investigation is ongoing.Medwatch field e1 facility name - the full facility name was provided as (b)(6).

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with elecsys anti-hbc ii on a cobas e 801 analytical unit.No questionable results were reported outside of the laboratory.The initial values did not match the clinical diagnosis of the patients.The first sample initially resulted in an anti-hbc value of 2.35 coi (non-reactive) and it repeated with a value of 0.436 coi (reactive).The repeat value matched the patient's previous result.The second sample initially resulted in an anti-hbc value of 2.69 coi (non-reactive) and it repeated with a value of 0.00814 (reactive).The repeat value matched the patient's previous result.

Manufacturer Narrative

Maintenance was performed on the analyzer and the issue did not occur again.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-HBC II
• Type of Device: HEPATITIS B TEST (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: 18931280
• MDR Text Key: 338078592
• Report Number: 1823260-2024-00806
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P100032
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09014926190
• Device Lot Number: 747118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2024
• 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