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

Catalog Number ASKU

Device Problem False Positive Result (1227)

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

Event Date 04/04/2023

Event Type  malfunction  

Manufacturer Narrative

Sample material was requested for investigation.H3 other text.

Event Description

The initial reporter stated they received discrepant positive results for one patient sample tested with the elecsys anti-hbs assay on a cobas 6000 e 601 module, serial number (b)(4).An interference with "rituximab" is suspected.The date of the event is not known.Reportedly the complained sample was measured "either march or (b)(6) 2023" and is marked as "patient sample of (b)(6) 2023" in the attachment.Refer to the attachment for all relevant test data.The discrepant positive results were confirmed in double.The use of heterophilic blocking tubes (hbt) did not change the results.

Manufacturer Narrative

The sample from (b)(6) 2023 with the reactive anti-hbs result was not provided for investigation.A sample from (b)(6) 2023 was submitted for investigation and tested for hbsag ii (2.73 coi, reactive).The investigation reproduced the customer's results.Further testing was not possible due to the low sample volume provided.The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

In relation to the attached data on the initial report for the competitor (non-roche assays): the patient sample of (b)(6) 2023 was reactive for cmv igm.

• Brand Name: ELECSYS ANTI-HBS IMMUNOASSAY
• 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: 16832181
• MDR Text Key: 314181456
• Report Number: 1823260-2023-01426
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup,Followup
• Report Date: 07/13/2023

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 Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 05/03/2023; 05/11/2023; 06/16/2023
• Supplement Dates FDA Received: 05/03/2023; 05/19/2023; 07/13/2023
• 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
• Treatment: ANTI PD1 NIVOLUMAB INJECTION; BENDAMUSTINE; RITUXIMAB