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

Model Number 6801925

Device Problems False Negative Result (1225); False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2022

Event Type  malfunction  

Event 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 one 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 600429.

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.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK
• Type of Device: 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: 16097132
• MDR Text Key: 307210605
• Report Number: 3007111389-2023-00004
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 10758750001682
• UDI-Public: 10758750001682
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2023
• Device Model Number: 6801925
• Device Catalogue Number: 6801925
• Device Lot Number: 3990
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1