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

Catalog Number 05894816190

Device Problem High Test Results (2457)

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

Event Date 09/21/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received questionable positive results for two samples collected from the same patient tested with elecsys anti-hbs ii on a cobas 6000 e601 module.The first sample collected on (b)(6) 2023 resulted in an anti-hbs value of 30.3 iu/l (positive) when tested on the e601 analyzer.The second sample collected on (b)(6) 2023 initially resulted in an anti-hbs value of 40.1 iu/l (positive) when tested on the e601 analyzer on (b)(6) 2023.The sample was repeated on a competitor system on (b)(6) 2023, resulting in an anti-hbs value of 1.51 (negative).No units of measure were provided for the competitor assay.

Manufacturer Narrative

The serial number of the e601 analyzer is (b)(6).It was noted that the analyzer had incorrect wash settings.The customer stated that they corrected the settings, but it is not known if this was done before or after the event.The competitor method is abbott alinity.The investigation is ongoing.

Manufacturer Narrative

The patient data has been clarified as follows: for the first sample collected on (b)(6) 2023, the anti-hbs value was 30.25 iu/l (positive).For the second sample collected on (b)(6) 2023, the initial anti-hbs value was 40.13 iu/l (positive).

• 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: 18565696
• MDR Text Key: 333506430
• Report Number: 1823260-2024-00207
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): Y
• 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
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05894816190
• Device Lot Number: 670997
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• 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