MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4; IN-VITRO DIAGNOSTICS

Catalog Number	1204668
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined lower than expected vitros bilirubin unconjugated (bu) results were obtained from a vitros performance verifier ii lot a2114 fluid tested using vitros bu slide lot 0238-0469-9224 on a vitros xt 7600 integrated system.The lower than expected results were obtained after calibrating the vitros bu assay.The assignable cause of the event is related to the calibration in use at the time that the results were obtained.The calibration in use had extremely atypical parameters, however, the cause of the atypical parameters is unknown.It is possible that the vitros calibrator kit 4 fluids were not reconstituted properly or that incorrect fluids were processed on the vitros instrument, however, this could not be confirmed.Results for the vitros pv fluid returned to expectations following a recalibration event.The customer performed maintenance actions on the vitros xt 7600 system including the correction factors adjustment and microslide incubator cleaning prior to the recalibration event and therefore, an instrument related issue cannot be ruled out as a contributing factor of the suboptimal calibration.However, the magnitude of bias observed with the results obtained from the suboptimal calibration and the bias of the parameters of that calibration would likely not be corrected through the maintenance actions performed.Additionally, no diagnostic precision testing was performed on the vitros xt 7600 system to verity instrument performance.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros bilirubin unconjugated (bu) results were obtained from a vitros performance verifier ii lot a2114 fluid tested using vitros bu slide lot 0238-0469-9224 on a vitros xt 7600 integrated system.The lower-than-expected result was obtained after calibrating the vitros bu assay.Vitros pv ii lot a2114 bu results of <-0.3, <-0.3, <-0.3, and <-0.3 mg/dl versus the range of mean midpoint result of 8.90 mg/dl 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 bu results were obtained from a non-patient quality control fluid, and patient results were not affected.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 CHEMISTRY PRODUCTS CALIBRATOR KIT 4
• 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, INC.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20737620
• Report Number: 1319808-2024-00042
• Device Sequence Number: 18331782
• Product Code: JIT
• UDI-Device Identifier: 10758750008537
• UDI-Public: (01)10758750008537(17)250701(11)230701(10)0423
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/20/2024

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: 07/01/2025
• Device Catalogue Number: 1204668
• Device Lot Number: 0423
• 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: 10/25/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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