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

Catalog Number 08814864160

Device Problem False Negative Result (1225)

Patient Problems Hepatitis (1897); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2022

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 307788622
• Report Number: 1823260-2022-03699
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 07613336198278
• UDI-Public: 07613336198278
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160019
• 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: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male