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

Catalog Number	6801428
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a false negative anti-hbc (ahbc) result was obtained when a vitros ahbc level 2 reactive control (lot 1240) was tested using vitros ahbc reagent lot 2780 on a vitros xt7600 integrated system.A definitive cause of the event was not established.A vitros ahbc lot 2780 reagent issue is an unlikely contributor to the event as qc results from mas and vitros ahbc control testing were deemed acceptable prior to and following the event.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ahbc reagent lot 2780 there was no evidence of a malfunction, however, as no diagnostic precision testing was conducted to verify the performance of the vitros xt7600 integrated system, an instrument issue cannot be ruled out as a contributor to the event.A pre-analytical handling issue cannot be ruled out as a contributor to the event as no information was provided when requested in relation to the handling of the vitros ahbc level 2 reactive control around up to the event.The customer confirmed that they had no further issues with vitros ahbc results since the latest event and that a new vial of the vitros ahbc level 2 reactive controls resolved the issue.An issue isolated to a single vitros ahbc level 2 reactive control vial cannot be ruled out as a contributor to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a false negative anti-hbc (ahbc) result was obtained when a vitros ahbc level 2 reactive control (lot 1240) was tested using vitros ahbc reagent lot 2780 on a vitros xt7600 integrated system.Vitros ahbc result of 1.22 s/c (negative) versus the expected result of reactive biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The false negative vitros ahbc result was obtained when the customer was processing a non-patient fluid and was not reported from the laboratory.There was no allegation of patient harm as a result of this event.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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 19179975
• Report Number: 3007111389-2024-00091
• Device Sequence Number: 20610462
• 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
• 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): 04/23/2024

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: 09/27/2024
• Device Catalogue Number: 6801428
• Device Lot Number: 2780
• 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: 03/27/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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