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	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, higher than expected b-hcg ii result was obtained when a single patient sample was tested using vitros b-hcg ii lot: 4720 on a vitros 5600 integrated system.A definitive cause of the event was not established.There was no evidence to suggest any issues with the performance of vitros b-hcg ii lot: 4720 at the customer site and ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros b-hcg reagent lot: 4720.An instrument issue is an unlikely cause of the event as there was no evidence or any suggestion from the customer that the instrument was not performing as intended.However, no within run diagnostic testing was conducted on the vitros 5600 integrated system, therefore an instrument related issue cannot be completely ruled out as a contributor to the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was not possible to determine whether the customer was not following the sample collection device manufacture recommendation for sample centrifugation and cellular debris, due to poor sample preparation, was likely present in the affected sample, although this could not be confirmed.The patient sample did not appear turbid and patient sample mix up was ruled out as a contributor to the event by the customer.
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 ii result obtained when a single patient sample was tested using vitros immunodiagnostic products total b hcg ii reagent pack ii lot: 4720 on a vitros 5600 integrated system.Patient 1, sample 1 result of 193 miu/ml versus the repeat vitros b-hcg ii results 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 b-hcg ii result was not reported from the laboratory.There has been no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (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: 24747158
• Report Number: 3007111389-2026-00069
• Device Sequence Number: 18328955
• Product Code: DHA
• UDI-Device Identifier: 10758750002320
• UDI-Public: (01)10758750002320(17)260721(10)250807(10)4720
• 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): 03/31/2026

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: 07/21/2026
• Device Catalogue Number: 6802220
• Device Lot Number: 4720
• 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: 03/13/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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