MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANTI-HBS ELECSYS E2G 300; ANTI-HBS TEST

Catalog Number 08343594160

Device Problem False Negative Result (1225)

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

Event Date 12/29/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The field service engineer (fse) performed an instrument check successfully.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys anti-hbs immunoassay results for 1 patient on a cobas e 801 analytical unit.This medwatch will cover anti-hbs.Refer to medwatch with a1 patient identifier (b)(6) for information on the hbsag results.On (b)(6) 2023, the patient had an anti-hbs of <3.5 miu/ml, intepreted as negative, and an hbsag result of reactive.The initial results were questioned which prompted a new sample to be collected for the patient.On (b)(6) 2023, the patient had an anti-hbs of 136 miu/ml, interpreted as positive, and an hbsag result of non-reactive.The sample was repeated and the results were confirmed.On (b)(6) 2023, the patient had another sample collected and the anti-hbs result was 173 miu/ml, interpreted as positive, and the hbsag result was non-reactive.The sample was repeated and the results were confirmed.

Manufacturer Narrative

The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ANTI-HBS ELECSYS E2G 300
• Type of Device: ANTI-HBS 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: 18571911
• MDR Text Key: 333612808
• Report Number: 1823260-2024-00214
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 07613336154014
• UDI-Public: 07613336154014
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08343594160
• Device Lot Number: 72300601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• 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