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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that discordant, reactive anti-hbc (ahbc) results were obtained when a single patient sample was tested using vitros ahbc lot 2730 on a vitros xt7600 integrated system.The results were considered discordant when compared to a negative non-vitros roche result for the same patient sample.A definitive cause of the event was not established.Historical qc results indicate acceptable vitros ahbc lot 2730 reagent performance and 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 2730.There was no evidence of an instrument malfunction, however, as no diagnostic precision testing was conducted around the time of the event, an instrument issue cannot be completely ruled out as a contributor to the event.However, as vitros ahbs results from qc testing were acceptable, it is likely the instrument was performing as expected around the time of the event.In addition, it was not possible to establish if the customer was following the sample collection device manufacturer¿s recommended centrifugation protocol; therefore, pre-analytical sample processing cannot be ruled out as a contributing factor.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.It is possible an interferent that affects the vitros ahbc method and not the roche ahbc method contributed to the event.There was no sample remaining from patient 1 to conduct further investigational testing.Therefore, the presence of a sample specific interferent cannot be ruled out as contributing to this event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, reactive anti-hbc (ahbc) results were obtained when a single patient sample was tested using vitros ahbc lot 2730 on a vitros xt7600 integrated system.The results were considered discordant when compared to a negative non-vitros roche result for the same patient sample.Patient 1, vitros ahbc results of 0.58, 0.56 and 0.51 s/c (reactive) versus the roche result of negative biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, reactive vitros ahbc 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 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17831885
• Report Number: 3007111389-2023-00172
• Device Sequence Number: 3390015
• Product Code: LOM
• UDI-Device Identifier: 10758750001217
• UDI-Public: 10758750001217
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 09/27/2023

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: 12/15/2023
• Device Catalogue Number: 6801428
• Device Lot Number: 2730
• 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: 09/05/2023
• Initial Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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