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

Catalog Number	6842781
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant non-reactive vitros hiv combo results were obtained from a reactive vitros hiv p24 antigen qc fluid lot 0150 when using vitros immunodiagnostics products hiv combo (hivc) reagent lot 0950 in conjunction with a vitros 3600 immunodiagnostic system.Vitros hiv p24 antigen qc results of 0.49, 0.60 and 0.84 s/c (negative) vs.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 on patient samples.The discordant vitros hiv combo results were from non-patient fluid and were not reported outside the laboratory.Ortho has not been made aware of any 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
The investigation determined that discordant non-reactive vitros hiv combo results were obtained from a reactive vitros hiv p24 antigen qc fluid lot 0150 when using vitros immunodiagnostics products hiv combo (hivc) reagent lot 0950 in conjunction with a vitros 3600 immunodiagnostic system.A definitive assignable cause cannot be determined.The customer made no suggestion of any issues with the other qc fluids processed at the customer site and no issues regarding accuracy or precision of the vitros assay were indicated by the customer up to (b)(6) 2023.The customer did not perform any precision testing on the instrument so no assessment of the instrument performance at the time of the event was made.Additionally, the ortho tsc established that the reagent cooling had shut down on the instrument up to five (5) days before the discordant p24 qc fluid results were obtained.Therefore, it cannot be confirmed that the instrument was operating as intended and unexpected instrument performance and the condition of the vitros hiv combo reagents cannot be completely ruled out as contributing to the event.Vitros p24 qc fluid handling, transportation and storage cannot be ruled out as a contributor to the event as it was determined that the control fluid may not have been supplied in the expected condition (frozen) to the customer site.

• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18483490
• Report Number: 3007111389-2024-00004
• Device Sequence Number: 14133932
• Product Code: MZF
• UDI-Device Identifier: 10758750031580
• UDI-Public: 10758750031580
• Combination Product (Y/N): N
• Initial Reporter Country: KZ
• Number of Events Summarized: 1
• Summary Report (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): 01/09/2024

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: 06/25/2024
• Device Catalogue Number: 6842781
• Device Lot Number: 0950
• 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: 12/14/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• 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