MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG II REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	6802220
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation concluded that a non-reproducible, higher than expected result was obtained from a single patient sample using vitros b-hcg (bhcgii) reagent lot 4310 on a vitros 5600 integrated system.The definitive assignable cause could not be determined with the information provided.No historic quality control results obtained using vitros bhcgii reagent lot 4310 were provided when requested, therefore, it is not possible to assess the performance of vitros bhcgii reagent lot 4310 and a reagent related performance issue cannot be ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros bhcgii reagent lot 4310.An instrument cannot be completely ruled out as a contributing factor as precision testing to assess instrument performance was not performed by the customer at the time of the event.Therefore, it cannot be confirmed that the instrument was operating as intended and unexpected instrument performance cannot be completely ruled out as contributing to the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it is unknown if the customer was following the sample collection device manufacture's recommendation for sample centrifugation.Cellular debris, due to poor sample preparation, was potentially present in the affected sample, although this could not be confirmed.Finally, since the vitros 5600 integrated system is not interfaced to e-connectivity, and the customer did not collect data log files, it was not possible to review sample metering profiles for the initial and repeat testing events to investigate the possibility of pre-analytical sample mix-up.Therefore, pre-analytical sample mix-up cannot be ruled out or confirmed as contributing to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected result was obtained from a single patient sample using vitros b-hcg (bhcgii) reagent lot 4310 on a vitros 5600 integrated system.Patient sample vitros bhcgii result of 28.7 miu/ml versus the repeat result of < 2.39 miu/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.It is unknown if the higher than expected vitros bhcgii result of 28.7 miu/ml was reported outside of the laboratory or if a correct report was issued.However, the customer confirmed that there has been no allegation of patient harm.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 609211.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG II 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: 21610314
• Report Number: 3007111389-2025-00022
• Device Sequence Number: 18081736
• Product Code: DHA
• UDI-Device Identifier: 10758750002320
• UDI-Public: (01)10758750002320(17)250629(11)240716(10)4310
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/14/2025

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: 06/29/2025
• Device Catalogue Number: 6802220
• Device Lot Number: 4310
• 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: 02/16/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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