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

Catalog Number	6801925
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined reproducible, discordant positive vitros ahbs results were obtained from a single patient sample tested on two different vitros xt7600 integrated systems using vitros ahbs reagent lot 5200.The vitros ahbs positive results were discordant when compared to anti-hbs negative results obtained from the same sample tested using a non-vitros roche cobas and a fuji rebio limipulse systems, and on two alternate vitros ahbs reagent lots 5160 and 5230.The assignable cause of the event is unknown.A performance issue with vitros ahbs reagent lot 5200 cannot be ruled out as a contributing factor as the ahbs positive results were isolated to reagent lot 5200.The customer obtained ahbs negative results from the same sample tested using two alternate vitros ahbs reagent lots and from two non-vitros anti-hbs methods.A review of historical quality control results obtained using vitros ahbs reagent lot 5200 indicated acceptable performance.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros ahbs reagent lot 5200.The customer did not perform any precision testing on the instrument and no mention of an assessment of the instrument performance at the time of the event was made.Therefore, an instrument performance issue cannot be ruled out as contributor to the event.No information was provided concerning pre-analytical sample processing.It was not possible to establish if the customer was following the sample collection device manufactures recommendation for sample centrifugation and cellular debris, due to poor sample preparation, was potentially present in the affected sample.However, since the vitros discordant reactive results were reproducible, improper pre-analytical sample processing did not likely contribute to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report reproducible discordant positive results obtained from a patient sample processed using vitros anti-hbs (ahbs) reagent lot 5200 on two vitros xt7600 integrated systems when compared to anti-hbs negative results obtained from two non-vitros systems as well as alternate vitros anti-hbs reagent lots.Vitros anti-hbs results 30.9, 28.8 miu/ml (>12 is antibody pos) vs.The expected result of negative.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant positive vitros ahbs results were not reported from the laboratory and 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) complaint number (b)(4) and reportability assessment 608544.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS 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: 21112142
• Report Number: 3007111389-2025-00005
• Device Sequence Number: 8760175
• Product Code: LOM
• UDI-Device Identifier: 10758750001682
• UDI-Public: (01)10758750001682(17)250322(11)240701(10)5200
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/08/2025

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: 03/22/2025
• Device Catalogue Number: 6801925
• Device Lot Number: 5200
• 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: 12/11/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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