MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 32; IN-VITRO DIAGNOSTICS

Model Number	6844508
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation concludes that lower than expected vitros sodium (na+) results were obtained when processing level 2 biorad liquichek unassayed chemistry control, lot 92960 after a calibration event due to the change in lots of reference fluid.In addition to the lower than expected vitros na+ results noted above, when reviewing the historical quality control results it was determined the customer obtained a higher than expected vitros na+ result when processing level 1 biorad liquichek unassayed chemistry control lot 92960.The cause of the lower than expected vitros na+ results is an unknown protocol issue resulting in a suboptimal calibration.A recalibration of vitros na+ was performed using a fresh set of vitros calibrator kit 32 fluids and a fresh reservoir of reference fluid properly warmed prior to use resulting in acceptable quality control results.A definitive assignable cause of the higher than expected vitros na+ results could not be determined.The customer repeated the testing of the level 1 biorad control on the same day and obtained an acceptable result of 125.2 mmol/l.It is unknown what actions the customer took to resolve the higher than expected vitros na+ quality control result.An issue with the vitros xt 7600 system is not a likely contributor of the higher than expected vitros na+ result identified during the review of historical quality control results.The acceptable within run vitros na+ precision test verifies the vitros xt7600 performance.The unacceptable within laboratory precision observed when evaluating the historical quality control results and the higher than expected vitros na+ quality control result is likely caused by day-to-day protocol issues related to fluid handling.The vitros xt 7600 and vitros na+ lot 4228-1113-4053 are performing as expected after the recalibration event and are not likely contributors of both the higher and lower than expected vitros na+ results.Improper protocol when handling calibrator fluids and/or reference fluid is the most likely contributor of the two events.Continual tracking and trending of complaints has not identified any signals that would point to potential systemic issues with vitros chemistry products na+ slides, lot 4228-1113-4053 or vitros calibrator kit 32 lot 3232.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros sodium (na+) results were obtained when processing level 2 biorad liquichek unassayed chemistry control, lot 92960 after a calibration event due to the change in lots of reference fluid.Vitros na+ results 143.8 and 144.5 versus the baseline mean of 155.3 umol/l in addition to the lower than expected vitros na+ results noted above, when reviewing the historical quality control results it was determined the customer obtained a higher than expected vitros na+ result when processing level 1 biorad liquichek unassayed chemistry control lot 92960.Vitros na+ result of 138.1 mmol/l versus the baseline mean of 125.3 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 and lower than expected vitros na+ results were obtained from quality control fluids.The customer also obtained lower than expected vitros na+ results when processing patient samples as part of their calibration verification procedure.The testing of patient samples was performed to verify the accuracy of the calibration and were not reported outside of the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number two of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 32
• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18636011
• Report Number: 1319808-2024-00002
• Device Sequence Number: 8092286
• Product Code: JIX
• UDI-Device Identifier: 10758750032105
• UDI-Public: 10758750032105
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2024

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: 01/23/2025
• Device Model Number: 6844508
• Device Catalogue Number: 6844508
• 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: 01/05/2024
• Initial Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown