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	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).Calibration and qc are within the acceptable range.A review of the alarm trace showed that on (b)(6) 2025, there were many alarms regarding sample foam detection, sample clot detection, sample probe, and abnormal aspiration.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable elecsys anti-hav igm assay result for a patient sample tested on a cobas e 801 analytical unit.The elecsys anti-hav igm result was reactive (1.04 coi).The cnr result was negative.The pcr result was negative.
Additional Manufacturer Narrative
Based on the multiple sample quality alarms at sample testing time, the issue was determined to be due to pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.The investigation did not identify a product problem.

• 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: 23556192
• Report Number: 1823260-2025-04647
• Device Sequence Number: 10053096
• Product Code: LOL
• UDI-Device Identifier: 04015630939855
• UDI-Public: 04015630939855
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/09/2026

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: 07026773190
• Device Lot Number: 848988
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 04/09/2026
• 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