MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HCV II; ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Catalog Number	07026889190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).All initially reactive or borderline samples should be retested in duplicate using the elecsys anti-hcv ii assay.Confirmation via supplemental methods (e.G.Immunoblot or detection of hcv rna).If one or both measurements remain borderline the analysis of a follow-up sample is recommended.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.False reactive results may occur in elecsys anti-hcv ii, as the assay has a labeled specificity of < 100%.The elecsys anti-hcv ii assay performs within specification.
Event or Problem Description
The initial reporter stated they received false positive results for two samples collected from the same patient tested with elecsys anti-hcv ii on a cobas e 801 analytical unit.No questionable results were reported outside of the laboratory.The results did not agree with the patient's clinical diagnosis.The first sample initially resulted in an anti-hcv value of 145 coi (reactive).The sample was repeated, resulting in a value of 144 coi (reactive).The sample was tested using the autobio antu method, resulting in an anti-hcv value of 0.107 (negative).The sample was also repeated using the maglumi snibe anti-hcv method, resulting in a value of 0.56 (negative).The sample was tested for hcv ag and it was negative.The sample was also tested for hcv rna and it was negative.The units of measure used for the antu and snibe methods were not provided.A second sample collected from the patient resulted in a reactive result when tested with the elecsys anti-hcv method.

• Brand Name: ELECSYS ANTI-HCV II
• Common Device Name: ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
• 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: 25187507
• Report Number: 1823260-2026-01926
• Device Sequence Number: 18725526
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P140021
• 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
• Report Date (Section B): 05/15/2026

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: 07/31/2026
• Device Catalogue Number: 07026889190
• Device Lot Number: 88101601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/15/2026
• 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 Age: 74 YR
• Patient Sex: Female