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

Catalog Number	6177333
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that discordant, reactive syphilis (syph2) results were obtained when two samples from the same patient were tested using vitros syph2 lot 0020 on a vitros 5600 integrated system.The results for the patient were discordant when compared to non-vitros syph results for the patient.The customer made no indication issues with quality control (qc) results from vitros syph2 lot 0020 testing around the time of the event and indicated qc results were within acceptable limits.Additionally, ongoing tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros syph2 lot 0020.As no diagnostic precision testing was conducted to verify the performance of the vitros 5600 integrated system, an instrument-related issue cannot be completely ruled out as a contributor to the event.However, there was no evidence of instrument-related issues and there was no report of any issues with vitros syph2 results from qc testing on the instrument.It is possible method to method differences contributed to the discordant, reactive vitros syph2 results, however, this could not be confirmed.The vitros syph2 results from testing of a sample from the patient using a non-specific antibody blocking tube (nabt) suggests nonspecific interference is an unlikely cause of the event.However, an interferent in the patient sample cannot be completely ruled out as a contributor to the event as no further investigational testing was conducted to rule out a sample specific interferent.A definitive assignable cause could not be determined.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report that discordant, reactive syphilis (syph2) results were obtained when two samples from the same patient were tested using vitros syph2 lot 0020 on a vitros 5600 integrated system.The results for the patient were discordant when compared to non-vitros syph results for the patient.Patient 1, results of 1.74 and 2.47 s/c (reactive) versus the non-vitros syph results of negative biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, reactive vitros syph2 results for the patient were not reported from the laboratory.There has been no allegation of patient harm as a result of this event.This report is number one of two 3500a forms being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS SYPHILIS 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: 22140612
• Report Number: 3007111389-2025-00068
• Device Sequence Number: 7356584
• Product Code: LIP
• UDI-Device Identifier: 10758750035052
• UDI-Public: (01)10758750035052(17)250610(11)241114(10)0020
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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: 06/10/2025
• Device Catalogue Number: 6177333
• Device Lot Number: 0020
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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