MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HBSAG II; TEST, HEPATITIS B

Catalog Number	08814864160
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	Hepatitis (1897); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable false negative hbsag g2 elecsys results from cobas 8000 cobas e 602 module serial number (b)(4).The initial result was 0.75 coi (negative).The customer recentrifuged the sample and repeated testing with a result of <1.0 coi (negative) repeatedly.The customer tested the sample on an abbott architect and received 1.02 (positive) for the screening test and 87.64% (positive) for the confirmation.The physician believed the results from abbott and that the patient is hepatitis positive as he tested positive five months ago for hep core assay.
Additional Manufacturer Narrative
The calibration and qc data were acceptable.The field service engineer reviewed the calibration and qc for the assay and believed there was likely interference in the patient sample.The investigation is ongoing.
Additional Manufacturer Narrative
A sample from the patent was submitted for investigation and the negative hbsag result could be reproduced.The hbsag ii result was 0.509 coi (non-reactive).The anti-hbs ii result was 2.00 with a data flag.The a-hbc ii result was 0.005 coi (reactive).No reagent-specific issue could be identified and the reagent met the specifications.As insufficient sample material was available, no further investigation was possible.Medwatch field b6 - relevant test/laboratory data was updated.

• Brand Name: ELECSYS HBSAG II
• Common Device Name: TEST, HEPATITIS B
• 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: 15833469
• Report Number: 1823260-2022-03699
• Device Sequence Number: 17499591
• Product Code: LOM
• UDI-Device Identifier: 07613336198278
• UDI-Public: 07613336198278
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 12/13/2022

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: 11/30/2022
• Device Catalogue Number: 08814864160
• Device Lot Number: 60868100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 59 YR
• Patient Sex: Male