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	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected b-hcg result was obtained from a single patient sample when using vitros immunodiagnostics product b-hcg ii, reagent lot 4910, on a vitros xt 7600 integrated system.The result was considered discordant when a repeat test was performed using the same sample.Patient 1, sample 1 vitros b-hcg ii result of 1289.8 miu/ml vs.The expected sample 1 result of <2.4 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 b-hcg ii result was reported from the laboratory and questioned by the physician.However, no treatment was initiated, altered, or stopped based on the reported result.There was 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).
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, higher than expected b-hcg result was obtained from a single patient sample when using vitros immunodiagnostics product b-hcg ii, reagent lot 4910, on a vitros xt 7600 integrated system.The result was considered discordant when a repeat test was performed using the same sample.The assignable cause of the non-reproducible, higher than expected patient sample result could not be determined.No issues were reported with the qc fluids processed at the customer site, and no concerns were raised regarding the accuracy or precision of the vitros assay as historical qc results were determined to be within expectations.However, as there was not an adequate number of results available for vitros b-hch ii lot 4910 to make a thorough evaluation, a reagent related issue cannot be entirely ruled out as a contributor of the event.The customer gave no indication of any instrument malfunction however, as no diagnostic within run precision testing was performed to verify performance, an instrument issue cannot be completely ruled out as a potential contributor to the event.Pre-analytical sample processing could not be ruled out as a contributing factor, as it was not possible to determine whether the customer was following the sample collection device manufactures recommendation for sample centrifugation, consequently, improper pre-analytical sample handling could have contributed to this 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, pre-analytical sample mix-up was ruled out as a contributor of the event.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros bhcg reagent lot 4910.

• 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: 25184949
• Report Number: 3007111389-2026-00099
• Device Sequence Number: 13437462
• Product Code: DHA
• UDI-Device Identifier: 10758750002320
• UDI-Public: (01)10758750002320(17)270118(11)260205(10)4910
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/14/2026

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 Catalogue Number: 6802220
• Device Lot Number: 4910
• 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: 04/22/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2026
• 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