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	11/12/2024
Type of Reportable Event	Malfunction
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 on a vitros 5600 integrated system.A definitive cause for the higher than expected patient sample result could not be determined.There is no package insert value assignment or peer data for the non-vitros biorad quality control fluid lot 94950 used by the customer for vitros b-hcg as the control does not support the vitros b-hcg ii assay.Subsequently, the non-vitros biorad qc fluid (94950) is not a suitable control to use with the b-hcg ii assay.Therefore, the vitros b-hcg reagent cannot be ruled out as a contributing factor of the event.Additionally, 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 as no manufacturer's recommendation was available.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.Furthermore, an instrument related issue cannot be ruled out as a contributing factor of the event as no diagnostic precision testing was performed on the vitros 5600 system.The customer informed the ortho tsc that the age of the patient is 51 and the clinical diagnosis for the patient at the time of the event was abnormal uterine bleeding and no medication had been administered to the patient.Therefore, an issue related to the patient's condition at the time of the event cannot be ruled out as a contributing factor of the event, although this cannot be confirmed.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 4310.
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 on a vitros 5600 integrated system.Patient 1 vitros b-hcg ii result of 203.690 miu/ml vs.The expected vitros b-hcg ii result of 0.230 miu/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher 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: 20859584
• Report Number: 3007111389-2024-00230
• Device Sequence Number: 19841656
• Product Code: DHA
• UDI-Device Identifier: 10758750002320
• UDI-Public: (01)10758750002320(17)250629(11)240716(10)4310
• 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): 12/05/2024

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: 06/29/2025
• Device Catalogue Number: 6802220
• Device Lot Number: 4310
• 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: 11/12/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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