MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBC IGM; HEPATITIS B TEST

Catalog Number	07026811160
Medical Device Problem Codes	False Positive Result (1227); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for approximately 7 patient samples tested using two different lot numbers of elecsys anti-hbc igm on a cobas e 801 analytical unit.For approximately 5 patient samples tested using anti-hbc igm reagent lot number 81987901 (expiration date = 31-may-2025), all samples had positive anti-hbc igm results and negative results for anti-hbc total.The customer stated it was not possible for samples to have positive anti-hbc igm results with negative anti-hbc total results.A second anti-hbc igm reagent lot number was sent to the customer.This reagent lot number is unknown.Two subsequent samples (samples 6 and 7) were tested using this new reagent and both samples had positive anti-hbc igm results and negative anti-hbc total results.The customer did not allege there were any issues with the anti-hbc total assay results.
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The last calibration was performed on (b)(6) 2024.Quality controls recovered within range.There is no indication of a reagent performance issue.Upon review of the alarm trace, sample short alarms and sample clot detection alarms were observed.These are indicators of possible poor sample quality.System reagent and sample probe alarms were also observed.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-HBC IGM
• Common Device Name: 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: 21079494
• Report Number: 1823260-2025-00033
• Device Sequence Number: 8333713
• Product Code: LOM
• UDI-Device Identifier: 07613336153932
• UDI-Public: 07613336153932
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P110022
• 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): 01/16/2025

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: 05/31/2025
• Device Catalogue Number: 07026811160
• Device Lot Number: 81987901, ASKU
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALBUTEROL - 1 PUFF (PATIENT 1).; BREO ELLLIPTA - 1 PUFF (PATIENT 1).; PRILOSEC - BID (PATIENT 1).; XANAX - BID (PATIENT 1).
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 104 KG