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

Model Number	6801428
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that discordant, non-reactive vitros anti-hbc (ahbc) results and discordant, positive vitros anti-hbs (ahbs) samples from one patient were tested using vitros ahbc lot 2680 and vitros ahbs lot 3990 on a vitros 5600 immunodiagnostic system.The vitros results were considered discordant when compared to results from a non-vitros (abbott) method.The assignable cause of the discordant, vitros ahbc and vitros ahbs results for the patient is the presence of a sample interferent present in the patient samples that were tested.The discordant vitros ahbc and vitros ahbs results were not reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, non-reactive vitros anti-hbc (ahbc) results and discordant, positive vitros anti-hbs (ahbs) samples from one patient were tested using vitros ahbc lot 2680 and vitros ahbs lot 3990 on a vitros 5600 immunodiagnostic system.The vitros results were considered discordant when compared to results from a non-vitros (abbott) method.Patient 1, vitros ahbs results of 40.76 and 48.27 miu/l (positive) versus the expected result of negative patient 1, vitros ahbc result of 1.98 and 1.87 s/c (non-reactive) versus the expected result of reactive the discordant vitros ahbc and vitros ahbs results were not reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number two of two mdr¿s 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 (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16097139
• Report Number: 3007111389-2023-00003
• Device Sequence Number: 12423334
• Product Code: LOM
• UDI-Device Identifier: 10758750001217
• UDI-Public: 10758750001217
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (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): 01/03/2023

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: 06/13/2023
• Device Model Number: 6801428
• Device Catalogue Number: 6801428
• Device Lot Number: 2680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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