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	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected vitros total b-hcg ii (bhcg) result was obtained from initial testing of a single patient sample using vitros bhcg lot 3780 on a vitros xt7600 integrated system.The result was lower than expected when compared to the repeat result using the same patient sample run on the same vitros xt 7600 system.Patient sample 1 bhcg result of <2.39 miu/ml versus the expected patient sample 1 result of 8.8 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 vitros bhcg result was reported outside of the laboratory.A corrected report was later issued and no treatment was stopped, started or altered based on the lower than expected result.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment 603553.
Additional Manufacturer Narrative
The investigation has determined that a lower than expected vitros total b-hcg ii (bhcg) result was obtained from initial testing of a single patient sample using vitros bhcg lot 3780 on a vitros xt7600 integrated system.The result was lower than expected when compared to the repeat result using the same patient sample run on the same vitros xt 7600 system.The assignable cause of the event is unknown.Within the timeframe of the event, historic vitros bhcg quality control results were acceptable, indicating vitros bhcg reagent lot 3780 was performing as intended and did not likely contribute to the event.Although diagnostic within run precision testing was not performed, acceptable historic vitros bhcg quality control results give no indication the vitros xt7600 integrated system was not performing as intended.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros bhcg reagent lot 3780.It is unknown whether the customer was following the collection device manufacturers recommendations for sample handling, and an issue with pre-analytical sample handling cannot be ruled out as a contributor to the initial lower than expected result.Additionally, the customer did not process the sample repeats within the timeframe of ortho¿s recommended sample storage protocol.However, the results from the sample that was redrawn six days after the initial sample confirm the patients positive pregnancy status, indicating that the repeat results of the initial sample are likely accurate.

• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17975069
• Report Number: 3007111389-2023-00184
• Device Sequence Number: 16767191
• Product Code: DHA
• UDI-Device Identifier: 10758750002320
• UDI-Public: 10758750002320
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 10/19/2023

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: 03/09/2024
• Device Catalogue Number: 6802220
• Device Lot Number: 3780
• 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: 09/25/2023
• Initial Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• 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