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

Catalog Number	6842781
Medical Device Problem Codes	False Negative Result (1225); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a discordant, non-reactive (negative) vitros hivc result was obtained from a single patient sample processed using vitros immunodiagnostic products hivc reagent lot 1230 on a vitros xt 7600 integrated system.The result was considered discordant when compared to the result using a non-vitros biomerieux vidas hiv duo ag/ab method obtained from the same sample.A definitive assignable cause of the event was not able to be determined.However, an issue related to the limitation of detection of the vitros hivc assay due to the patient having an early infection is the most likely cause of the event.A second sample for the patient collected and processed approximately one week after the initial testing yielded a reactive vitros hivc result.The customer confirmed that the patient was in the hiv seroconversion phase (phase of early hiv infection) around the time of the initial testing event that produced the discordant, non-reactive vitros hivc result.Quality control results for the vitros hivc reagent lot 1230 were within expectations prior to the event.Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros hivc lot 1230.No precision testing was performed on the vitros xt 7600 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 at the time of the event.Pre-analytical sample processing can be ruled out as a contributing factor as the customer was following the sample collection device manufacturer recommended centrifugation protocol.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a discordant, non-reactive (negative) vitros hivc result was obtained from a single patient sample processed using vitros immunodiagnostic products hiv combo (hivc) reagent lot 1230 on a vitros xt 7600 integrated system.The result was considered discordant when compared to the result using a non-vitros biomerieux vidas hiv duo ag/ab method obtained from the same sample.Patient sample result of 0.12 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 hivc result was not reported from the laboratory.There have been no reported allegations 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 HIV COMBO 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: 22529891
• Report Number: 3007111389-2025-00092
• Device Sequence Number: 7932563
• Product Code: MZF
• UDI-Device Identifier: 10758750031580
• UDI-Public: (01)10758750031580(17)260317(11)250411(10)1230
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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: 03/17/2026
• Device Catalogue Number: 6842781
• Device Lot Number: 1230
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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