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

Model Number 6801925

Device Problem High Test Results (2457)

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

Event Date 05/24/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected anti-hbs (ahbs) results were obtained when testing a non-vitros (biorad) negative quality control (qc) fluid using a vitros ahbs reagent on a vitros xt 7600 immunodiagnostic system.A definitive assignable cause of the events was not determined with the information provided.There is no indication of an instrument malfunction; however, the customer did not perform a within run precision testing at the time of the events to definitively rule out an instrument issue.In addition, the customer is not following the manufacturer¿s recommended sample handling protocol; therefore, pre-analytical sample processing cannot be ruled out as a contributing factor.It is possible that the qc samples were not at room temperature when the samples were processed, although this could not be confirmed.The complaint review did not indicate a quality performance issue with vitros ahbs reagent lot 8931.However, it is possible that the higher than expected vitros ahbs results was due to the biorad viroclear lot 106550 qc fluid, although this could not be confirmed.Biorad has opened an investigation of biorad viroclear lot 106550, however, no conclusion has been reached at this time.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ahbs.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected anti-hbs (ahbs) results were obtained when testing a non-vitros (biorad) negative quality control (qc) fluid using a vitros ahbs reagent on a vitros xt 7600 immunodiagnostic system.Vitros ahbs results of 12.6784, 12.8649 and 14.2543 miu/ml versus expected results of negative.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros ahb results were obtained from non-patient fluids.Ortho has not been made aware of any allegation of patient harm as a result of this events.This report is number two of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three 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-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: 17184130
• MDR Text Key: 318126165
• Report Number: 3007111389-2023-00101
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 10758750001682
• UDI-Public: 10758750001682
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2023
• Device Model Number: 6801925
• Device Catalogue Number: 6801925
• Device Lot Number: 8931
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1