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

Catalog Number	08837031190
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The anti-hcv ii reagent expiration date was not provided.The cobas e411 rack serial number was (b)(6).Calibration on 25-apr-2024 was within the expected ranges.Qc was acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about questionable low results for 1 patient sample tested with elecsys anti-hcv g2 (anti-hcv ii) assay on a cobas e411 immunoassay analyzer when compared to a competitor's platform (abbott).Initial result: 0.073 coi which was interpreted as non-reactive (negative).1st repeat result: 0.67 s/co (tested on the abbott platform and interpreted as non-reactive/negative).2nd repeat result: 0.123 coi which was interpreted as non-reactive (negative).3rd repeat result: 0.97 s/co (tested on the abbott platform and interpreted as non-reactive/negative).4th repeat result: 0.070 coi which was interpreted as non-reactive (negative).5th repeat result: 1.47 s/co (tested on the abbott platform and interpreted as reactive).The sample was then sent to another site and tested on a siemens platform and the 6th repeat result was consistent with roche's results.The customer expected a positive result for the patient.No questionable results were reported outside the laboratory.
Additional Manufacturer Narrative
The instrument's maintenance was performed according to specifications.The investigation did not identify a product problem.The elecsys anti-hcv ii assay performs within specifications.The cause of the event could not be determined.

• 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: 19509841
• Report Number: 1823260-2024-01719
• Device Sequence Number: 3418523
• Product Code: MZO
• UDI-Device Identifier: 07613336166970
• UDI-Public: 07613336166970
• Combination Product (Y/N): Y
• Initial Reporter Country: PK
• 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): 07/18/2024

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 Catalogue Number: 08837031190
• Device Lot Number: 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: 05/17/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/18/2024
• 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