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

Catalog Number	08836981190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas 6000 e601 module and a cobas e 411 analyzer (serial number: (b)(6).The investigation determined that the elecsys anti-hcv ii assay performed within specifications.Further investigation included testing two vials of the same patient sample (labeled vial a and vial b) with the elecsys anti-hcv ii assay on the cobas 6000 e601 module.Vial a generated a result of 3.93 coi (reactive), and vial b generated a result of 3.95 coi (reactive), reproducing the customer¿s initial results.Additional testing with the fujirebio innolia hcv score assay yielded negative results for both vials, with a weak line observed for ns3.A review of calibration and quality control data confirmed all results were within the specified range.The investigation concluded that the observed results were unspecific false reactive results, which are covered by the claimed specificity of the assay.The root cause was attributed to unspecific false reactive results.The customer was advised to use rack adapters during sample processing to minimize the risk of incorrect results.
Event or Problem Description
The initial reporter alleged discrepant positive results for one patient sample tested with the anti-hcv g2 elecsys cobas e 100 v2 assay on the cobas 6000 e601 module and the cobas e 411 analyzer.On (b)(6) 2022 at 09:18, the sample was tested on the cobas 6000 e601 module and generated a result of 3.94 coi (reactive).On (b)(6) 2022 at 10:05, the same sample was tested on the cobas e 411 analyzer and generated a result of 3.44 coi (reactive).Testing of the same sample on the abbott alinity system yielded a result of 0.45 s/co (negative).The results were not reported to the patient.

• 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: 23067256
• Report Number: 1823260-2025-02947
• Device Sequence Number: 21298857
• Product Code: MZO
• UDI-Device Identifier: 07613336166956
• UDI-Public: 07613336166956
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K221693
• 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): 09/16/2025

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: 02/28/2023
• Device Catalogue Number: 08836981190
• Device Lot Number: 63337901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2022
• Initial Report FDA Received Date: 09/16/2025
• 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