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

Catalog Number	1933027
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that lower than expected vitros prostatic specific antigen (psa) results were obtained from a single level of non-vitros biorad lot 85330 quality control fluid and a single level of non-vitros fuji rebio tumor marker controls lot 49820 using vitros psa reagent lot 4340 tested on a vitros xt 7600 integrated system.The most likely assignable cause of the event was atypical calibrations.Acceptable vitros psa performance was obtained after a calibration event using an alternate set of the same lot of calibrators, with no additional actions taken to optimize the vitros xt7600 integrated system.The customer could not confirm if these atypical calibrations were all performed using the same set of calibrators, however, the customer checked the refrigerator and there is only 1 set of opened vitros psa lot 4340 calibrators, therefore, it is likely all of these calibrations were performed on the same set of calibrators.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros psa reagent lot 4340.An instrument related performance issue did not likely contribute to the event as diagnostic within-run precision testing indicated the vitros xt7600 integrated system was performing as intended.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros prostatic specific antigen (psa) results were obtained from a single level of non-vitros biorad lot 85330 quality control fluid and a single level of non-vitros fuji rebio tumor marker controls lot 49820 using vitros psa reagent lot 4340 tested on a vitros xt 7600 integrated system.The biorad results were lower than expected when compared to the customer¿s baseline mean and the fuji rebio result was lower than expected when compared to the package insert mean.Biorad level 2 vitros psa results of 1.43 and 1.45 ng/ml vs.The expected psa result of 1.98 ng/ml fuji rebio level 1 vitros psa result of 2.31 ng/ml vs.The expected psa result of 3.21 ng/ml 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 results were obtained from non-patient quality control samples.The customer made no indication that patient samples were affected however, the investigation cannot confirm patient results would not be affected in the event were to recur undetected.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 (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
• 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: 17882022
• Report Number: 3007111389-2023-00174
• Device Sequence Number: 20757024
• Product Code: JIT
• UDI-Device Identifier: 10758750000319
• UDI-Public: 10758750000319
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/03/2023

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: 02/21/2024
• Device Catalogue Number: 1933027
• Device Lot Number: 4340
• 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: 09/12/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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