MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9; IN-VITRO DIAGNOSTICS

Model Number	8568040
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher and lower than expected phenobarbital (phbr) results were obtained from two levels of non-vitros biorad qc fluid and from one level of vitros therapeutic drug monitoring (tdm) performance verifier (pv) fluids using vitros chemistry products phbr slides lot 2504-0091-0846 on a vitros xt7600 integrated system.The assignable cause for the higher and lower than expected results of 16.43 and 15.68 that were obtained prior to the calibration on 05 apr 2023 is unknown.The calibration that was in use at the time that these results is not available for review, therefore it is unknown if the calibration for these results was a contributor to the event.The assignable cause for the remaining lower and higher than expected results of 7.07, 10.11, 10.26, 10.32 and 98.99 is a suboptimal calibration, although the cause of the suboptimal calibration is unknown.A new calibration was performed with parameters that were more typical to expectation, and acceptable results were obtained at that time with no changes in reagent or actions to the analyzer.An issue with immunowash fluid (iwf) fluid handling cannot be confirmed or ruled out as a contributor to the events.The customer did not provide their protocol for iwf handling when requested.There is no indication that the vitros xt7600 integrated system or the vitros phbr reagent malfunctioned in any way.Vitros tdm performance verifier results were within expectation following the most recent calibration performed with new calibrator fluids, a new vitros phbr cartridge and new iwf fluid with no other actions performed to the analyzer.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros phbr reagent lot 2504-0091-0846.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher and lower than expected phenobarbital (phbr) results were obtained from two levels of non-vitros biorad qc fluid and from one level of vitros therapeutic drug monitoring (tdm) performance verifier (pv) fluids using vitros chemistry products phbr slides lot 2504-0091-0846 on a vitros xt7600 integrated system.Tdm pvi lot k9187 vitros phbr results of 10.11, 10.26 and 10.32 ug/ml versus the expected result of 13.56 ug/ml biorad level 1 lot 85311 vitros phbr results of 7.07, 16.43 and 15.68 ug/ ml versus the expected result of 10.3 ug/ml biorad level 3 lot 85313 vitros phbr result of 98.99 ug/ ml versus the expected result of 73.3 ug/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 higher and lower than expected vitros phbr results were obtained from a quality control fluid and no results were reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number three of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 601758.

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9
• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16868641
• Report Number: 0001319808-2023-00008
• Device Sequence Number: 5460340
• Product Code: JIT
• UDI-Device Identifier: 10758750005031
• UDI-Public: 10758750005031
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 05/03/2023

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: 06/06/2024
• Device Model Number: 8568040
• Device Catalogue Number: 8568040
• Device Lot Number: 942
• 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: 04/06/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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