MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HAV IGM; HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

Catalog Number	07026773190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 module serial number was (b)(6).Sample material from the patient was requested for further investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys anti-hav igm results from the cobas e 801 module.The anti-hav igm result was 2.25 coi (reactive).The anti-hav g2 result was 1.17 coi (non-reactive).Using a different cobas instrument, the anti-hav igm result was 2.07 coi (reactive) and the anti-hav g2 result was 1.15 coi (non-reactive).The patient went to another laboratory, and the having result was non-reactive.The method used was not known.
Additional Manufacturer Narrative
For further investigation, the received patient sample was retested, and the customer's results were reproduced.The sample was then tested with three different lots of elecsys anti-hav igm reagent, and all the results were reactive.Further testing found the sample was falsely reactive for elecsys anti-hav igm due to the presence of igm directed against the ruthenium-label of the assay.Per product labeling for the assay: in rare cases, interference due to high titers of antibodies to immunological components, streptavidin or ruthenium can occur.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The reagent performed within specification.

• Brand Name: ELECSYS ANTI-HAV IGM
• Common Device Name: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
• 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: 22726298
• Report Number: 1823260-2025-02407
• Device Sequence Number: 8989661
• Product Code: LOL
• UDI-Device Identifier: 04015630939855
• UDI-Public: 04015630939855
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093955
• 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): 12/02/2025

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: 07026773190
• Device Lot Number: 84898801
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 12/02/2025
• 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