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	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a discordant non-reactive vitros anti-hcv result from a single patient sample when tested using a vitros anti-hcv reagent lot 5551 on a vitros 3600 immunodiagnostic system.The result was considered discordant when compared to positive results obtained from a non-vitros recombinant immunoblot assay (riba) method and repeat testing on the vitros system.Patient 1 vitros anti-hcv result of 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 anti-hcv result was not reported from the laboratory and there was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
A customer reported a discordant non-reactive vitros anti-hcv result from a single patient sample when tested using a vitros anti-hcv reagent lot 5551 on a vitros 3600 immunodiagnostic system.The result was considered discordant when compared to positive results obtained from a non-vitros recombinant immunoblot assay (riba) method and repeat testing on the vitros system.A definitive assignable cause could not be determined.A potential cause of the event was an unknown sample related issue associated with the initial test event, all subsequent testing produced the expected reactive result.Based on the historical quality control results provided the customer, a vitros anti-hcv reagent lot 5551 performance issue is not a likely contributor to the event.Qc data obtained by the ortho tsc were within the appropriate classification areas.Within run precision testing on the instrument obtained results within ortho guidelines indicating an instrument issue is not a likely contributor to the event.However, as this within run precision testing was not performed at the time of the event and instrument issue cannot be completely ruled out as contributing to the event.In addition, it was not possible to establish if the customer is following the sample collection device manufacturer's recommended centrifugation protocol; therefore, pre-analytical sample processing cannot be ruled out as a contributing factor.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros anti hcv reagent lot 5551.

• 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 19173281
• Report Number: 3007111389-2024-00092
• Device Sequence Number: 17967981
• Product Code: MZO
• UDI-Device Identifier: 10758750001095
• UDI-Public: 10758750001095
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 04/24/2024

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: 06/05/2024
• Device Catalogue Number: 6801325
• Device Lot Number: 5551
• 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: 03/27/2024
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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