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

Model Number 6801756

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 315935465
• Report Number: 3007111389-2023-00081
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 10758750001309
• UDI-Public: 10758750001309
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1