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	04/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a lower than expected total b-hcg ii result was obtained from a single patient sample when using vitros immunodiagnostic products total b-hcg ii (b-hcg ii)reagent on a vitros 3600 immunodiagnostic system.The result was considered discordant when compared to a non-vitros beckman method using the same patient sample.A definitive cause for the lower than expected patient sample result could not be determined.Historical qc fluid performance indicates a vitros b-hcg ii lot 4490 performance issue is not a likely contributor to the event.However, as no package insert information for the controls used at the site was provided, a reagent related issue cannot be entirely ruled out as a contributor of the event.No precision testing was performed on the vitros 3600 immunodiagnostic system at the time of the event and therefore, an instrument related issue cannot be entirely ruled out as a contributor of the events.However, historical vitros qc fluid results were accurate and precise, and no evidence of any instrument malfunction were reported, therefore, an instrument issue is an unlikely cause of the event.Pre-analytical sample processing cannot be ruled out as a contributing factor as it was not possible to determine whether the customer was following the sample collection device manufacture's recommendation for sample centrifugation.Therefore, 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.Additionally, an ortho laboratory specialist stated that it is recommended that the sample be placed in the sample tube for 30 minutes prior to centrifugation according to the requirements of the coagulation tube used.It is unknown if this requirement was followed, and an issue related to improper protocol cannot be entirely ruled out as a contributing factor of the event.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros b-hcg lot 4490.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower-than-expected total b-hcg ii result was obtained from a single patient sample when using vitros immunodiagnostic products total b-hcg ii (b-hcg ii) reagent on a vitros 3600 immunodiagnostic system.The result was considered discordant when compared to a non-vitros beckman method using the same patient sample.Patient 1 vitros b-hcg ii result of <2.39 miu/ml vs.The expected result of 11.00 miu/ml biased results of the magnitude and direction observed may led to inappropriate physician action if they were to occur undetected.The lower-than-expected vitros b-hcg result was not reported from the laboratory.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).

• 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: 21970668
• Report Number: 3007111389-2025-00061
• Device Sequence Number: 18268525
• 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): 05/06/2025

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: 04/12/2025
• Initial Report FDA Received Date: 05/06/2025
• 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