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

Catalog Number	6801325
Medical Device Problem Codes	False Negative Result (1225); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report that discordant negative vitros hiv combo (hivc) results were obtained from two different levels of vitros anti-hiv 1+2 lot 1160 controls and discordant negative vitros hepatitis c virus (hcv) results were obtained from a single level of vitros anti-hcv lot 1580 control.The results were obtained when tested on a vitros 3600 immunodiagnostic system.Vitros anti-hiv 1+2 lot 1160 l2 control vitros hivc results of 0.22, 0.23, 0.24 and 0.18 s/c (negative) vs.The expected result of >/=1.00 s/c (reactive).Vitros anti-hiv 1+2 lot 1160 l3 control vitros hivc result of 0.13 s/c (negative) vs.The expected result of >/=1.00 s/c (reactive).Vitros anti-hcv lot 1580 reactive control vitros ahcv reagent lot 5810 results of 0.080, 0.060, 0.049, 0.025, 0.009 and 0.018 s/c (negative) vs.The expected result of >/=1.00 s/c (reactive).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.There was no allegation of patient harm as a result of this event.This report is number two of two 3500a forms are 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).
Additional Manufacturer Narrative
The customer reported that discordant negative vitros hivc results were obtained from two different levels of vitros anti-hiv 1+2 lot 1160 controls and discordant negative vitros hcv results were obtained from a single level of vitros anti-hcv lot 1580 control.The results were obtained when tested on a vitros 3600 immunodiagnostic system.The assignable cause of the discordant, negative results lower than expected results was a reagent pack related issue.The affected vitros hivc lot 1170 results were isolated to reagent pack id (b)(4) and the affected vitros anti-hcv lot 5810 results were isolated to reagent pack id (b)(4).Acceptable results were obtained from alternate reagent packs from the same reagent lots.The issue with the affected reagent pack is unknown, however, improper reagent pack storage cannot be ruled out as contributing to the event.The affected vitros hivc reagent pack was stored open unloaded from the instrument for 24 hours and the vitros anti-hcv reagent pack was stored open unloaded from the instrument for 48 hours.The vitros hivc and ahcv instructions for use states that opened reagent packs stored offboard should be refrigerated in a sealed reagent pack storage box that contains dry desiccant.No information was provided concerning how vitros hivc pack id (b)(4) and vitros ahcv pack id (b)(4) were stored while unloaded from the vitros 3600 immunodiagnostic system.Therefore, improper reagent pack storage cannot be ruled out as contributing to the event.Quality control results obtained from vitros hivc reagent lot 1170 and vitros anti-hcv reagent lot 5810 were acceptable using alternate reagent packs prior to, and after the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with hivc reagent lot 1170 or vitros anti-hcv reagent lot 5810.In addition, there is no indication the vitros 3600 immunodiagnostic system malfunctioned as the erroneous results were isolated to the two affected reagent packs.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV 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: 22479719
• Report Number: 3007111389-2025-00084
• Device Sequence Number: 20879115
• Product Code: MZO
• UDI-Device Identifier: 10758750001095
• UDI-Public: (01)10758750001095(17)250911(11)250114(10)5810
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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: 09/11/2025
• Device Catalogue Number: 6801325
• Device Lot Number: 5810
• 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: 06/18/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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