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

Catalog Number	08086664190
Medical Device Problem Codes	False Negative Result (1225); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Calibration and controls were acceptable.Based on this data, the assay works within specifications.Based on analyzer data, the gear pump head and syringe seal have reached their life time limit.System data also indicated that system reagent cup emptying maintenance and a mixer check were significantly overdue.The results of five of the patient samples were very close to the cutoff both in 2024 and in 2025.Based on analysis, there was no overall trend of an increase of results in the range of 0.9-1.1 coi observed over four previously released lots.The root cause for the issue observed with the third sample could not be determined.For diagnostic purposes, the results should always be assessed in conjunction with the patients' medical history, clinical examination and other findings.The labeled specificity of the elecsys anti-hav 2 assay is <100%.Single false reactive results can occur.
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable non-reactive results for six patient samples tested with elecsys anti-hav ii on a cobas e 801 analytical unit.Previous samples from these patients had reactive results.The first patient sample resulted in anti-hav values of 1.02 iu/l (non-reactive), 1.02 iu/l (non-reactive), and 1.02 iu/l (non-reactive).The second patient sample resulted in anti-hav values of 1.04 iu/l (non-reactive), 1.04 iu/l (non-reactive), and 1.04 iu/l (non-reactive).The third patient sample resulted in anti-hav values of 1.20 iu/l (non-reactive), 1.19 iu/l (non-reactive), and 1.20 iu/l (non-reactive) on (b)(6) 2025.The fourth patient sample resulted in anti-hav values of 1.07 iu/l (non-reactive), 1.04 iu/l (non-reactive), and 1.04 (non-reactive) on (b)(6) 2025.The fifth patient sample resulted in anti-hav values of 1.10 iu/l (non-reactive) and 1.10 iu/l (non-reactive) on (b)(6) 2025.The sixth patient sample resulted in anti-hav values of 1.06 iu/l (non-reactive) and 1.07 iu/l (non-reactive) on (b)(6) 2026.

• 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: 24191138
• Report Number: 1823260-2026-00292
• Device Sequence Number: 21294810
• Product Code: LOL
• UDI-Device Identifier: 07613336129715
• UDI-Public: 07613336129715
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 03/30/2026

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 Expiration Date: 08/31/2026
• 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): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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