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

Catalog Number	08086630190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter establishment name: (b)(6).The analyzer's serial number is (b)(6).The samples were requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys anti-hav ii results for 2 patients on a cobas e 411 analyzer (rack system).Patient 1: the initial result was 0.976 coi (reactive).The confirmation results for the sample (using the abbott architect method) were nonreactive.The anti-hav igm result was 0.10, and the anti-hav igg result was 0.12.The units of measure for the confirmation results were not provided.Patient 2: the reporter stated that the patient's samples were repeatedly reactive.On (b)(6) 2024, the patient's result was 0.966 coi (reactive).On (b)(6) 2025, a new sample was obtained and the result was 0.955 coi (reactive).The confirmation results for the (b)(6) 2025 sample (using the abbott architect method) were nonreactive.The anti-hav igm result was 0.09, and the anti-hav igg result was 0.28.The units of measure for the confirmation results were not provided.
Additional Manufacturer Narrative
The calibration was last performed on 28-nov-2024.No additional calibration data was provided.The provided qc data in dec-2024, mar-2025, and apr-2025 were within specifications.The calibration lot from nov-2024 was used.The samples were requested for investigation, but are no longer available.Based on the calibration and qc data, the reagent performs within specifications.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." "analytical specificity / cross-reactivity: the specificity of the elecsys anti-hav ii assay on the cobas e 601 immunoassay analyzer was evaluated by testing a total of 120 samples (native human serum and plasma pools) positive for antibodies to a variety of disease states (ana, cmv, ebv, hbv, hcv, hiv, hsv, mumps/rubeola, parvovirus b19, rubella, toxoplasmosis gondii and treponema pallidum).Samples were measured with elecsys anti-hav assay and elecsys anti-hav ii assay on the cobas e 601 immunoassay analyzer.No discrepant results or cross-reactivity with antibodies to other infectious agents were found." the investigation did not identify a product problem.

• 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: 21970651
• Report Number: 1823260-2025-01402
• Device Sequence Number: 8492636
• Product Code: LOL
• UDI-Device Identifier: 07613336129722
• UDI-Public: 07613336129722
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 08/05/2025

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: 08086630190
• Device Lot Number: 808346
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 08/05/2025
• 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 Sex: Unknown