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	02/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged a possible false positive result for one sample tested with the anti-hcv g2 elecsys e2g 300 assay on a cobas e 801 analytical unit.The sample was initially measured as reactive with the elecsys anti-hcv ii assay, yielding a result of 125 coi (reactive).This result was confirmed on (b)(6) 2020.Subsequent testing at the customer site using western blot yielded a negative result.
Additional Manufacturer Narrative
The analysis was performed on a cobas e 801 analyzer (serial number: (b)(6).The anti-hcv ii reagent expiration date was not provided.The sample was received for investigation.The sample, described as lipemic, was tested with a different lot of the elecsys anti-hcv ii reagent and yielded a reactive result of 135 coi.Additional testing using the fujirebio innolia hcv score assay produced an indeterminate result (ns4 2+).The western blot test performed at the customer site yielded a negative result.No definitive conclusion could be drawn due to the indeterminate blot result.It was noted that single false positive results are covered by the assay's specificity claim as outlined in the instructions for use (ifu).Further clarification would require additional clinical data, patient history, or a follow-up sample.The investigation determined that the elecsys anti-hcv ii assay performed within specifications, and a general reagent issue was excluded.

• 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: 23076894
• Report Number: 1823260-2025-03061
• Device Sequence Number: 10064281
• Product Code: MZO
• UDI-Device Identifier: 04015630939947
• UDI-Public: 04015630939947
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/17/2025

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: 444006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 09/17/2025
• 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