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	02/03/2026
Type of Reportable Event	Malfunction
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 two different samples from the same patient when using vitros immunodiagnostics product b-hcg ii, reagent lot 4740, on a vitros 5600 integrated system.Patient 1, sample 1 vitros b-hcg ii result of <2.39 miu/ml vs.The expected result of >15000 miu/ml patient 1, sample 2 vitros b-hcg ii result of <2.39 miu/ml vs.The expected result of >15000 miu/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected b-hcg ii results were not reported by the laboratory.There was no allegation of patient harm as a result of this event.This report is number two of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.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 lower than expected b-hcg results were obtained from two different samples from the same patient when using vitros immunodiagnostics product b-hcg ii, reagent lot 4740, on a vitros 5600 integrated system.The lower than expected patient sample results could not be determined with the information provided.A vitros tsh lot b-hcg ii reagent related issue is not a likely a contributor to the event as historical qc fluid results were accurate and precise.Additionally, ongoing tracking and trending does not indicate any performance concerns with these lots.No precision testing was performed on the vitros 5600 integrated systems at the time of the event and historical vitros qc fluid results were not precise, therefore, an instrument related issue cannot be entirely ruled out as a contributor of the events.The customer informed the ortho tsc that the patient samples were retested, yielding results of >15,000 miu/ml.The customer further suspected a sample mix-up, confirming that the initially lower than expected vitros b-hcg ii results were most likely due to patient sample mix-up, however, this was not confirmed.

• 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: 24524010
• Report Number: 3007111389-2026-00043
• Device Sequence Number: 8430461
• Product Code: DHA
• UDI-Device Identifier: 10758750002320
• UDI-Public: (01)10758750002320(17)260806(11)250819(10)4740
• 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): 03/05/2026

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 Expiration Date: 08/06/2026
• Device Catalogue Number: 6802220
• Device Lot Number: 4740
• 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: 02/06/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2025
• 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