MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBS II; HEPATITIS B TEST

Catalog Number 08498610190

Device Problems High Test Results (2457); Chemical Problem (2893); Non Reproducible Results (4029)

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

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

The e801 analyzer serial number is (b)(6).The competitor platform is abbott alinity.The investigation is ongoing.

Event Description

The initial reporter alleged they received discrepant results for one patient sample tested with elecsys anti-hbs ii on a cobas e 801 analytical unit.The sample resulted in an anti-hbs value of 62.3 miu/ml when tested on the e801 analyzer.The sample was repeated on a competitor platform, resulting in an anti-hbs value of 0.0 miu/ml.A second sample collected from the patient resulted in an anti-hbs value of < 2.00 miu/ml with a data flag when tested on the e801 analyzer on (b)(6) 2024.

Manufacturer Narrative

Calibration and controls were acceptable.Based on calibration and control recovery, the reagent performs within specification.Upon review of the alarm trace, no relevant alarms were observed.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-HBS II
• Type of Device: HEPATITIS B TEST
• 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: 18677323
• MDR Text Key: 335022668
• Report Number: 1823260-2024-00387
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P190034
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08498610190
• Device Lot Number: 716600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• 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