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	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that discordant, false reactive syph2 results were obtained when two different samples were tested using vitros syph2 lot 0010 across two vitros 3600 immunodiagnostic systems.The results for the samples were discordant when compared to non-vitros syph results for the samples.A definitive cause of the event was not established.In-house and selling qc fluids processed on the instruments on the date of the event indicate acceptable vitros syph2 lot 0010 reagent performance and ongoing tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros syph2 lot 0010.As no diagnostic precision testing was conducted to verify the performance of the vitros 3600 immunodiagnostic systems, instrument-related issues cannot be completely ruled out as a contributor to the event.However, there was no evidence of instrument-related issues and the vitros syph2 results from in-house and selling control testing were acceptable on both instruments.It is possible method to method differences contributed to the discordant, reactive vitros syph2 results, however, this could not be confirmed.In addition, an interference in the patient samples cannot be ruled out as a contributor to the event, as no investigational testing to rule out the presence of a sample specific interferent was conducted for the samples.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, false reactive syph2 results were obtained when two different samples were tested using vitros syph2 lot 0010 across two vitros 3600 immunodiagnostic systems.The results for the samples were discordant when compared to non-vitros syph results for the samples.Sample sd161 result of 2.30 s/c (reactive) versus the non-vitros syph results of non-reactive sample sa242 result of 2.71 s/c (reactive) versus the non-vitros syph results of non-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, reactive vitros syph2 results for the samples were obtained as part of internal testing conducted at ortho rochester and were not reported from laboratory.There was no allegation of patient harm as a result of this event.This report is number two of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) nonconformance (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: 20846875
• Report Number: 3007111389-2024-00229
• Device Sequence Number: 17086521
• Product Code: LIP
• UDI-Device Identifier: 10758750035052
• UDI-Public: (01)10758750035052(17)250407(11)240829(10)0010
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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: 04/07/2025
• Device Catalogue Number: 6177333
• Device Lot Number: 0010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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