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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An ortho clinical diagnostics (ortho) quality engineer (qe) reported a higher than expected vitros ahbs result was obtained when an inhouse control fluid was processed using vitros ahbs lot 8955 in combination with a vitros eci immunodiagnostic system as part of as part of internal post-expiry stability testing at ortho pencoed.In-house control c-a11 result of 17.0 miu/ml (positive) versus the expected result of ?2 miu/ml (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 ahbs result was obtained from a non-patient fluid as part of internal stability testing at ortho.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) nonconformance number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros ahbs result was obtained when an in-house control fluid was processed using vitros ahbs lot 8955 in combination with a vitros eci immunodiagnostic system as part of as part of internal post-expiry stability testing at ortho pencoed.The cause of the higher than expected result was a known issue with the vitros ahbs lot 8955 reagent.Vitros ahbs lot 8955 was one of the lots included in an ortho field action in (b)(6) 2023.A customer letter (b)(6) was issued in (b)(6) 2023 informing customers to discontinue use of certain vitros ahbs reagent lots due to an observed increase in calibration failures, imprecision, and ahbs quality control results falling outside of the expected range.The assignable cause of the issue is related to a specific raw material used in the manufacture of the conjugate reagent.

• 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: 19005510
• Report Number: 3007111389-2024-00063
• Device Sequence Number: 21191823
• Product Code: LOM
• UDI-Device Identifier: 10758750001682
• UDI-Public: 10758750001682
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2024

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: Other
• Device Expiration Date: 01/28/2024
• Device Catalogue Number: 6801925
• Device Lot Number: 8955
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown