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

Catalog Number 08498610190

Device Problem High Test Results (2457)

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

Event Date 12/18/2023

Event Type  malfunction  

Event Description

The initial reporter received a questionable elecsys anti-hbs result from one patient sample tested on the cobas e 801 analytical unit.The reporter stated that the initial result from the analyzer was deemed a false anti-hbs positive result as the patient has been a chronic hepatitis b carrier for years.The patient sample was then sent to another laboratory that uses an abbott alinity.The reporter stated that they explained the issue to the general practitioner (gp) and it was stated that the patient should be considered a carrier; no incorrect diagnosis was made.On (b)(6) 2023, the initial result from the analyzer was a value of 67 (positive).On (b)(6) 2023, the repeat result from the other laboratory was <2.00 iu/l (negative).This result was in line with the patient's previous results.

Manufacturer Narrative

The serial number of the customer's cobas e 801 analytical unit is (b)(6).The patient sample was received for investigation.The investigation is ongoing.

Manufacturer Narrative

The investigation reviewed the calibration on 17-nov-2023; the results were valid.The investigation reviewed the qc level 2 data provided; the results were mainly within specifications and stable.However, the results were at the lower limit.The qc level 2 after the calibration (it is assumed that this was on 17-dec-2023) was one of the results at the lower limit; it cannot be excluded that this was on the date of event (18-dec-2023) or if a rerun of qc level 2 was performed.The investigation tested the patient sample for anti-hbs ii using two different lots; the investigation was able to reproduce the customer's results.The investigation used an internal neutralization assay to check for the presence of anti-hbs in the patient sample.The investigation determined that based on the results of the neutralization approach, the positive anti-hbs ii result is assumed to be unspecific/false positive.The event was consistent with a lot-independent interference; single false reactive results can occur.Based on the calibration and qc results at the customer site and the additional testing performed at the investigation site, the reagent performed within specification.Product labeling states: "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.

• 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: 18580363
• MDR Text Key: 333735088
• Report Number: 1823260-2024-00226
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): Y
• Reporter Country Code: BE
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• 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: 71660001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• 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