MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK; IN-VITRO DIAGNOSTICS

Model Number	6801756
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected quality control results obtained from a non-vitros biorad quality control (qc) fluid when using vitros immunodiagnostics products psa (psa) reagent in combination with two vitros xt 7600 integrated systems.Vitros psa reagent lot 4290 on vitros xt 7600 integrated system (j1): biorad immunoassay plus control level 2 results of 2.127, 2.139 and 2.156 ng/ml versus an expected result of 3.100 ng/ml no vitros psa results met potential health and safety criteria for on vitros xt 7600 integrated system (j2).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected vitros psa results were from non-patient fluid and were not reported from the laboratory.The customer did not give any indication that patient results had been affected and there is 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 602006.
Additional Manufacturer Narrative
The investigation determined that lower than expected quality control results obtained from a non-vitros biorad quality control (qc) fluid when using vitros immunodiagnostics products psa (psa) reagent in combination with two vitros xt 7600 integrated systems.A definitive assignable cause for the lower than expected vitros psa results could not be determined with the information provided.No information was provided with regards to the handling of the qc samples between vitros psa testing events.It is possible improper handling of the qc samples contributed to the lower than expected vitros psa lot 4290 results, although this could not be confirmed.Instrument related performance issues did not likely contribute to the events as the customer gave no indication of any instrument malfunction however, as no diagnostic within run precision testing was performed, an instrument issue cannot be completely ruled out as a potential contributor to the event.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros psa lot 4290.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS PSA 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: 16995038
• Report Number: 3007111389-2023-00081
• Device Sequence Number: 7067562
• Product Code: LTJ
• UDI-Device Identifier: 10758750001309
• UDI-Public: 10758750001309
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/24/2023

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: 06/28/2023
• Device Model Number: 6801756
• Device Catalogue Number: 6801756
• Device Lot Number: 4290
• 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: 05/01/2023
• Initial Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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