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

Catalog Number	08343594160
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The field service engineer (fse) performed an instrument check successfully.The investigation is ongoing.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2024-00214
• Device Sequence Number: 18204484
• Product Code: LOM
• UDI-Device Identifier: 07613336154014
• UDI-Public: 07613336154014
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 08343594160
• Device Lot Number: 72300601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown