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	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about questionable high results for 13 patients' samples tested with elecsys anti-hav ii assay on a cobas e 801 module when compared to the competitor's method.Initial results: reactive.Repeat results: non-reactive.The customer observed an increased number of a-hav ii results in the range of 0.6 coi to 0.99 coi, which were also discrepant when compared to the competitor's results.Three other samples showed borderline negative values of 1.01 coi, 1.02 coi, and 1.02 coi upon re-measurement.
Additional Manufacturer Narrative
The anti-hav ii reagent expiration date was not provided.The cobas e 801 module serial number was 18m0-10.Qc was acceptable.The sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Seventeen samples were received for investigation and were tested on a cobas pro e 801 using the elecsys anti-hav assay, lot numbers 868268 and 911314.The investigation results were as follows: - no lot difference was seen (except for sample 14).- 11 out of the 17 samples were found reactive with both lot numbers.- 5 samples (samples 1, 4, 5, 8, and 15 ) were non-reactive with both lot numbers.- sample 14 has discrepant results between the two anti-hav lot numbers (the results from both lots were very near the cut-off threshold).The investigation noted that unspecific reactive results can occur and are covered by the assay's specificity claim.The 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." a general product problem can be excluded since the qc results were acceptable.The investigation did not identify a product problem.The reagent performs within specifications.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23478680
• Report Number: 1823260-2025-04507
• Device Sequence Number: 13344577
• Product Code: LOL
• UDI-Device Identifier: 07613336129715
• UDI-Public: 07613336129715
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/27/2026

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: 868268
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 02/27/2026
• 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 Sex: Unknown