MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 5; IN-VITRO DIAGNOSTICS

Model Number	1149764
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros ammonia (amon) results were obtained from a non-vitros biorad quality control fluid processed using vitros chemistry products amon slides lot 1019-0259-0222 on a vitros 5600 integrated system.The assignable cause of the higher than expected vitros amon results is a suboptimal calibration.The parameters of the calibration used to obtain the results were determined to be atypical when compared to the database values.Acceptable results were obtained after a recalibration event.The cause of the suboptimal calibration is unknown.However, a possible cause of the suboptimal calibration is improper protocol as the customer could not confirm if the vitros cal kit 5 fluids used for the suboptimal calibration had been adequately brought to room temperature prior to being processed on the vitros 5600 system as required.Following a recalibration using fresh vials of vitros cal kit 5, vitros amon results returned to expectations using the biorad control fluids.Based on historical quality control results, a vitros amon lot 1019-0259-0222 is not a likely contributor of the event.Additionally, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon reagent lot 1019-0259-0222.Although precision testing was not performed on the vitros 5600 integrated system an instrument related issue is not a likely contributor of the event as quality control results were returned to expectations after a recalibration event without any known troubleshooting actions being performed on the instrument.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros ammonia (amon) results were obtained from a non-vitros biorad quality control fluid processed using vitros chemistry products amon slides lot 1019-0259-0222 on a vitros 5600 integrated system.Biorad control lot 54360 level 2 vitros amon results of 126.9, 123.0 and 120.8 umol/l versus an expected result of 93.1 umol/l 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 than expected vitros amon results were obtained when processing a control fluid.No results were reported out of the laboratory and the customer made no indication that patient sample results were affected or questioned.Ortho was not made aware of any 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 5
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1000 lee road; rochester NY 14606
• 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: 16547962
• Report Number: 0001319808-2023-00005
• Device Sequence Number: 6042613
• Product Code: CIX
• UDI-Device Identifier: 10758750008483
• UDI-Public: 10758750008483
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/15/2023

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: 06/20/2024
• Device Model Number: 1149764
• Device Catalogue Number: 1149764
• Device Lot Number: 0522
• 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: 02/16/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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