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	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a discordant, non-reactive vitros anti-hbc (ahbc) result from a single patient sample was obtained when tested using vitros ahbc lot 2710 on a vitros xt 7600 integrated system.The vitros result was considered discordant when compared to a non-vitros abbott result.A definitive assignable cause could not be determined.A review of historical quality control results obtained prior to the event confirmed the results were within the appropriate result interpretation, indicating acceptable performance of vitros anti-hbc lot 2710.Pre-analytical sample processing was ruled out as a contributing factor, as it was established that the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.Therefore, improper pre-analytical sample handling did not likely contribute to this event.It is possible an interferent that affects the vitros ahbc method and not the abbott ahbc method contributed to the discordant non-reactive ahbc result for the patient.However, as the customer did not carry out any further testing on the patient sample, this was not confirmed.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ahbc, lot 2710.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a discordant, non-reactive vitros anti-hbc (ahbc) result from a single patient sample was obtained when tested using vitros ahbc lot 2710 on a vitros xt 7600 integrated system.The vitros result was considered discordant when compared to a non-vitros abbott result.Vitros ahbc result of 1.93 s/c (non-reactive) vs.The expected result of positive.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, non-reactive vitros ahbc result was 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 corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(6) and reportability assessment 604644.

• 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: 18486984
• Report Number: 3007111389-2024-00007
• Device Sequence Number: 20630083
• 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): 01/10/2024

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: 11/16/2023
• Device Catalogue Number: 6801428
• Device Lot Number: 2710
• 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: 12/15/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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