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

Catalog Number	07026811160
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about questionable high results for 1 patient sample tested with elecsys anti-hbc igm on a cobas e801 analytical unit and not correlating to elecsys anti-hbc total result.The sample was initially tested twice at the same time.The initial results were 4.45 coi and 4.469 coi and they were interpreted as positive.The customer always tests for anti-hbc total when initially testing for anti-hbc igm.Anti-hbc total result: negative.The sample was then repeated resulting in an anti-hbc igm value of 1.93 coi.The negative result of anti-hbc total was deemed to be correct and reported to the physician.
Additional Manufacturer Narrative
The cobas e801 analytical unit serial number was (b)(6).The sample was requested for investigation on 07-feb-2025.The field service engineer (fse) checked the instrument and found no visual issue.The system was due for preventive maintenance.He performed preventive maintenance.The customer repeated the same sample and obtained the same results.The customer also mentioned that the issue started with the new lot of the reagent pack.Precision studies were performed and they were within specifications.The customer performed qc and it was within the ranges.The investigation is ongoing.
Additional Manufacturer Narrative
Based on calibration and qc data, the reagent performs within specifications.Two samples (sample 1 and sample 2) were received for investigation on 27-feb-2025.No information was provided on whether sample 1 and sample 2 were aliquots from the same patient or different patients, and/or if it is the sample in question.The investigation confirmed the elecsys anti-hbc igm reactive results obtained by the customer using 2 different elecsys anti-hbc igm lot numbers on cobas e601 and cobas e801.Sample 1: the addition of anti-label interference-eliminating substances to elecsys anti-hbc igm turned the result from initially reactive to non-reactive.The elecsys anti-hbc igm reactive result was considered false reactive.Sample 2: there was no hint of the presence of anti-label interferences.The investigation did not identify a product problem.The root cause was due to sample-specific interferences.

• 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: 21363262
• Report Number: 1823260-2025-00411
• Device Sequence Number: 15557570
• 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): 05/06/2025

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: 10/31/2025
• Device Catalogue Number: 07026811160
• Device Lot Number: 82696601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 05/06/2025
• 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: HUMIRA; IMMUNE SUPPRESSANTS
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American