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	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An internal ortho clinical diagnostics investigation reported discordant, false reactive syphilis 2 (syph2) results were obtained when a single ivdd negative panel sample was tested using vitros syph2 lot 0010 on a vitros 3600 immunodiagnostic system.N103 sample results of 1.71, 1.14, 4.49, 1.29, 1.00, 1.82, 1.59, 4.36, 4.61 s/c (reactive) versus the expected result 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 sample n103 were obtained as part of troubleshooting investigations conducted at ortho rochester and were not reported from laboratory.There has been no allegation of patient harm as a result of this event this report corresponds to ortho clinical diagnostics inc (ortho) nonconformance (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that discordant, false reactive syphilis 2 (syph2) results were obtained when a single ivdd negative panel sample was tested using vitros syph2 lot 0010 on a vitros 3600 immunodiagnostic system.A definitive cause of the event was not established.In-house and selling qc fluids processed on the instrument 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.There was no evidence of an instrument issue.In addition, the vitros syph2 results were reproducible across three different vials of sample n103 and the vitros syph2 results from in-house and selling control testing were acceptable.However, as no diagnostic precision testing was conducted to verify the performance of the vitros 3600 immunodiagnostic system, an instrument issue cannot be completely ruled out as a contributor to the event.Sample n103 is part of an ivdd negative panel of > 100 samples that are all expected to return non-reactive vitros syph2 results.The issue with reproducible false reactive results was isolated to sample n103 and there were no reported issues with alternate samples within the ivdd negative panel.Therefore, an unknown issue with sample n103 is a possible contributor to the event.

• 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, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20643631
• Report Number: 1319681-2024-00060
• Device Sequence Number: 7443418
• 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): 11/08/2024

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: 10/11/2024
• Initial Report FDA Received Date: 11/08/2024
• 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