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 Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected b-hcg results were obtained from a level 3 non-vitros mas omni immune quality control (qc) fluid lot oim2612 when tested using a vitros immunodiagnostics product total b-hcg ii reagent lot 4710 on a vitros xt 7600 integrated system.The assignable cause of the lower-than-expected qc sample results could not be determined.Calibration responses were within allowable ranges; however, suboptimal calibrations could not be entirely ruled out as a contributing factor of the event.Historical qc data revealed accuracy and precision concerns, but the number of data points were not sufficient to confirm or exclude a reagent-related issue.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros bhcg ii reagent lot 4710.The customer was requested to perform a diagnostic precision test to verify the performance of the vitros xt 7600 integrated system.However, the customer declined.As a result, an instrument-related issue cannot be ruled out as a contributing factor to this event.The customer stored the qc fluids in a freezer and thawed for one hour in the refrigerator prior to use, which does not meet non-vitros mas requirements for room-temperature thawing and immediate use.Therefore, improper pre-analytical qc fluid handling could not be ruled out as contributing to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected b-hcg results were obtained from a level 3 non-vitros mas omni immune quality control (qc) fluid lot oim2612 when tested using a vitros immunodiagnostics product total b-hcg ii reagent lot 4710 on a vitros xt 7600 integrated system.Mas lot oim2612 level 3 qc fluid results of 317.63 and 330.76 miu/ml vs.The expected result of 788.82 miu/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower-than-expected vitros b-hcg ii results were from non-patient fluid and were not reported from the laboratory.The customer did not give any indication that patient results had been affected, and 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 612639.

• 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 23604312
• Report Number: 3007111389-2025-00132
• Device Sequence Number: 15914861
• Product Code: DHA
• UDI-Device Identifier: 10758750002320
• UDI-Public: (01)10758750002320(17)260630(11)250724(10)4710
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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: 06/30/2026
• Device Catalogue Number: 6802220
• Device Lot Number: 4710
• 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: 10/30/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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