MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	6801325
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that discordant, non-reactive (negative) vitros ahcv results were obtained from a patient sample processed using vitros immunodiagnostic products ahcv reagent lots 5840, 5900 and 5921 on a vitros 3600 immunodiagnostic system.The results were considered discordant when compared to the results obtained using a non-vitros elisa (vector-best) method obtained from the same samples.A definitive assignable cause of the false negative results could not be determined with the information provided.According to the vitros ahcv ifu: a negative test result does not exclude the possibility of exposure to or infection with hcv.Hcv antibodies may be undetectable in some stages of the infection and in some clinical conditions.Based on historical quality control results, an issue related to the vitros ahcv reagent is not a likely contributor of the event.Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with the vitros ahcv reagent.No precision testing was performed on the vitros 3600 system at the time of the event and therefore, an instrument related issue cannot be entirely ruled out as a contributing factor of the event.However, there was no indication of an instrument related issue as qc results were within expectations.Pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the customer was following the sample collection device manufacturer's recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, non-reactive (negative) vitros ahcv results were obtained from a patient sample processed using vitros immunodiagnostic products ahcv reagent lots 5840, 5900 and 5921 on a vitros 3600 immunodiagnostic system.The results were considered discordant when compared to the results obtained using a non-vitros elisa (vector-best) method obtained from the same samples.Patient 2 results of 0.54 and 0.80 s/c (non-reactive) versus the expected result of reactive.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reactive vitros ahcv results were reported from the laboratory.However, no treatment was initiated, altered or stopped based on the reported results.There have been no reported allegations of patient harm as a result of this event.This report is number two of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 23424097
• Report Number: 3007111389-2025-00116
• Device Sequence Number: 8178993
• Product Code: MZO
• UDI-Device Identifier: 10758750001095
• UDI-Public: (01)10758750001095(17)251224(11)250430(10)5900
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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: 12/24/2025
• Device Catalogue Number: 6801325
• Device Lot Number: 5900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• 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