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	07/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that discordant negative anti-hcv results were obtained from two different samples from the same patient when using vitros anti-hcv reagent lot 5610 on a vitros eci immunodiagnostic system and a vitros 5600 integrated system.The results were considered discordant when compared to positive hcv results obtained on four non-vitros methods (elisa, vidas elfa, clia and western blot).The assignable cause of the discordant negative patient sample results could not be determined.A limitation of the vitros ahcv assay cannot be ruled out as a contributor to the event.The vitros ahcv assay detects the presence of igg antibodies only in patient samples, while it is unknown what antibodies are detected in the non-vitros methods.It is also possible that the infection was in the early stages where the antibody concentration may not be detectable.Based on historical quality control results, a vitros anti-hcv reagent lot 5610 performance issue is not a likely contributor to the event.Additionally, precision testing of the vitros eci immunodiagnostic system was not performed, therefore it cannot be confirmed that the instrument was operating as intended and unexpected instrument performance cannot be completely ruled out as contributing to the event.However, there was no indication that the vitros eci system or the alternate vitros 5600 system malfunctioned.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.Furthermore, the customer did not carry out any sample interference testing, therefore, it is possible that a sample interferent was present in the patient 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 negative anti-hcv results were obtained from two different samples from the same patient when using vitros anti-hcv reagent lot 5610 on a vitros eci immunodiagnostic system and a vitros 5600 integrated system.The results were considered discordant when compared to positive hcv results obtained on four non-vitros methods (elisa, vidas elfa, clia and western blot).Vitros eci (s/n (b)(6) results: patient 1, sample 1 result of 0.40 s/c (negative) vs expected result reactive patient 1, sample 2 result of 0.40 s/c (negative) vs expected result reactive vitros 5600 (s/n (b)(6) result: patient 1, sample 2 result of 0.31 s/c (negative) vs expected result reactive biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant negative vitros anti-hcv results were not reported from the laboratory.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).

• 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: 19932419
• Report Number: 3007111389-2024-00152
• Device Sequence Number: 16834252
• Product Code: MZO
• UDI-Device Identifier: 10758750001095
• UDI-Public: (01)10758750001095(17)241009(11)240209(10)5610
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 08/07/2024

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: 10/09/2024
• Device Catalogue Number: 6801325
• Device Lot Number: 5610
• 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: 07/11/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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