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	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a non-reproducible, higher than expected vitros total b-hcg (bhcg) result was obtained from a single patient sample processed using vitros immunodiagnostics products total bhcg ii reagent lot 4490 in combination with a vitros 5600 integrated system.The assignable cause of the event could not be determined with the information provided.Based on historical quality control results, a vitros bhcg lot 4490 performance issue is not a likely contributor to the event.No precision testing was performed on the vitros 5600 integrated system to verify instrument performance.However, an instrument related issue is not a likely contributing factor of the event as quality control results were within expectations.Additionally, acceptable repeat results for the patient were obtained from the same sample without any known actions being performed on the vitros 5600 system.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 manufacturer's recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Additionally, a pre-analytical sample-mix up could not be confirmed or ruled out as a contributor of the event as similar acceptable repeat results from the patient sample were obtained on an alternate vitros instrument as well as the initial instrument using both vitros bhcg lot 4490 and an alternate reagent lot.As the customer is not currently connected to e-connectivity, evaluation of data to confirm or rule out a sample mix-up was not possible.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros bhcg reagent lot 4490.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected vitros total b-hcg (bhcg) result was obtained from a single patient sample processed using vitros immunodiagnostics products total bhcg ii reagent lot 4490 in combination with a vitros 5600 integrated system.Patient sample result of 25.51 miu/ml versus an expected 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.The non-reproducible, higher than expected vitros bhcg result was not reported outside of the laboratory.There is no 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 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: 23572926
• Report Number: 3007111389-2025-00126
• Device Sequence Number: 18672064
• Product Code: DHA
• UDI-Device Identifier: 10758750002320
• UDI-Public: (01)10758750002320(17)251219(11)250113(10)4490
• 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): 11/17/2025

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: 12/19/2025
• Device Catalogue Number: 6802220
• Device Lot Number: 4490
• 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: 10/21/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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