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

Catalog Number	07026889190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas e 801 analyzer (serial number: (b)(6).The investigation determined that the issue was most likely hardware-related.Specifically, the blank cell calibration reports indicated that the analyzer (serial number: (b)(6) failed the m6 check, with channel 1 cv -pw being out of specification.Similar findings were observed on another connected analytical unit (serial number: (b)(6), while a third unit (serial number: (b)(6) was found to be within specifications.The investigation was limited due to the unavailability of calibration, quality control, and updated apc check data, which could not be performed due to pandemic-related restrictions.A definitive root cause for the reported event could not be determined based on the available information.The customer was advised to perform an apc check on the affected analytical units and to verify performance using a fresh anti-hcv ii reagent kit of the same lot across all modules.
Event or Problem Description
The initial reporter alleged discrepant anti-hcv g2 elecsys e2g 300 results between the cobas e 801 analytical unit and the cobas e 601 analyzer during a validation study.The reported results included the following: sample no.(b)(6) showed 39.54 coi on the cobas e 601 and 61.1/64 coi on the cobas e 801.Sample no.(b)(6) showed 21.35 coi on the cobas e 601 and 43.3/43.4 coi on the cobas e 801.Sample no.(b)(6) showed 22.78 coi on the cobas e 601 and 41.8/41.8 coi on the cobas e 801.

• 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: 23062495
• Report Number: 1823260-2025-02903
• Device Sequence Number: 13258737
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P140021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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 Catalogue Number: 07026889190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2020
• 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