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

Catalog Number	08837031190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two lot numbers of anti-hcv ii reagent were used.Patient 2 was tested using anti-hcv ii reagent lot number 748184 with an expiration date of 31-jul-2024.The cobas e411 rack serial number rack was (b)(6).The customer performs qc only on mondays.Two sample tubes were received for investigation on 16-may-2024.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with elecsys anti-hcv g2 (anti-hcv ii) assay on a cobas e411 immunoassay analyzer.Sample 1 (patient 2): patient 2 was diagnosed positive for anti-hcv in 2019.On (b)(6) 2024, a sample was drawn and tested on cobas e411 and the initial result was 0.092 coi (negative).The sample was repeated on the same day on the cobas e411 and the repeat result was 0.093 coi (negative).The original sample was sent to a different laboratory equipped with the cobas pro system but the results have not been provided yet.Sample 2 (patient 1): on (b)(6) 2024, a sample was initially tested on a competitor's (alinity) analyzer and obtained a result of 3.45 coi.On (b)(6) 2024, a new sample was drawn and tested on cobas e411 and obtained the result of 0.10 coi (negative).The sample was repeated on the same day on the cobas e411 and the repeat result was 0.098 coi (negative).This new sample was then sent to a different laboratory and obtained a positive result.The exact result was not provided.
Additional Manufacturer Narrative
The investigation of the 2 samples was performed on a cobas e411 using anti-hcv ii reagent lot number 748184 and fujirebio innolia hcv score lot number 411903.The 1st sample: anti-hcv ii result: 0.073 coi (non-reactive).Innolia result: negative.The 2nd sample (sample lipemic): anti-hcv ii result: 0.079 coi (non-reactive).Innolia result: negative.Due to the negative blot results, the elecsys anti-hcv ii results were considered to be true negative.The preanalytic data showed no abnormalities.No foam on the sample or the reagent was observed.The customer was advised to perform qc daily (not only on mondays), respectively every day before sample measurement to ensure that the reagent performs within specification.The investigation did not identify a product problem.The reagent performs within specifications.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19345781
• Report Number: 1823260-2024-01494
• Device Sequence Number: 20456090
• Product Code: MZO
• UDI-Device Identifier: 07613336166970
• UDI-Public: 07613336166970
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 06/24/2024

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: 04/30/2024
• Device Catalogue Number: 08837031190
• Device Lot Number: 733352, 748184
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/24/2024
• 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