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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a higher than expected total b-hcg ii (bhcg ii) result was obtained from a single patient sample when using vitros immunodiagnostics products bhcg ii reagent in combination with a vitros 5600 integrated system.The investigation was unable to determine an assignable cause for this event.The customer made no suggestion of any issues with the single level of non-vitros biorad lyphochek immunoassay plus control lot 40441 qc fluid processed at the customer site and no issues regarding accuracy or precision of the vitros assay were indicated.However, as the customer does not process control fluids across the measuring range of the assay, a reagent issue could not be entirely ruled out as contributing to the event.Additionally, an instrument cannot be completely ruled out as a contributing factor as precision testing to assess instrument performance was not performed by the customer at the time of the event and nor was a sample at a suitable concentration processed.Therefore, it cannot be confirmed that the instrument was operating as intended and unexpected instrument performance cannot be completely ruled out as contributing to the event.Furthermore, pre-analytical sample processing could not be ruled out as a contributing factor.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros bhcg ii reagent lot 4200.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected total b-hcg ii (bhcg ii) result was obtained from a single patient sample when using vitros immunodiagnostics products bhcg ii reagent in combination with a vitros 5600 integrated system.Patient 1 result of 41.23 miu/ml versus 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 from the laboratory and ortho has not been made aware of any 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: 20741518
• Report Number: 3007111389-2024-00220
• Device Sequence Number: 12852535
• Product Code: DHA
• UDI-Device Identifier: 10758750002320
• UDI-Public: (01)10758750002320(17)250405(11)240424(10)4200
• 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): 11/19/2024

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: 04/05/2025
• Device Catalogue Number: 6802220
• Device Lot Number: 4200
• 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: 10/25/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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