MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HAV II; HEPATITIS A TEST

Catalog Number	08086664190
Medical Device Problem Codes	False Positive Result (1227); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for eighteen patient samples tested with elecsys anti-hav ii on an unknown roche analyzer.The customer states the reactive results obtained with the roche anti-hav method are not consistent with competitor anti-hav igg and anti-hav igm results.Refer to the attachment for all patient data.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
18 patient samples were provided for investigation.Overall, a good comparability to the abbott igg assay was found.Good comparability to the alinity method was confirmed by a previously performed dilution sensitivity study, which confirms a robust performance of the elecsys anti-hav ii assays also in low antibody titer patients (close-to-the cutoff samples).Lot-to-lot difference cannot be excluded in close-to-cut-off samples as these samples may contain low concentrations of anti-hav antibodies, potentially resulting from a past infection, insufficient immune response after infection, or vaccination.Non-reactive does not mean the complete absence of hav-specific antibodies.No evidence for anti-hav igm was found in all 18 samples, thus the elecsys anti-hav igm non-reactive results are to be considered as correct.Sample tested elecsys reactive for anti-hav ii are therefore considered to be truly reactive for anti-hav igg antibodies, which was confirmed in 8 out of 11 samples by the abbott igg assay.In 2 of the 3 discrepancies, a history of hav-vaccination has been reported not detected by the abbott alinity assay (samples 1 and 6).Only for 1 sample, no additional evidence is provided which could confirm the elecsys positive status (sample 15).Elaborate investigations for potential interference were performed on this sample without evidence for an interference which could cause a reactive result in this sample.The status of this sample cannot be resolved.Overall, the anti-hav ii reagent performs within specification.Single discrepant reactive /non- reactive results can occur and are covered by the specificity and sensitivity claim of the assay.

• Brand Name: ELECSYS ANTI-HAV II
• Common Device Name: HEPATITIS A 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: 21885375
• Report Number: 1823260-2025-01238
• Device Sequence Number: 3442756
• Product Code: LOL
• UDI-Device Identifier: 07613336129715
• UDI-Public: 07613336129715
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K190428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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 Catalogue Number: 08086664190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 09/17/2025
• 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
• Patient Age: 73 YR
• Patient Sex: Male