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

Catalog Number	8568040
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros phyt quality control results were obtained from a vitros tdm iii pv qc fluid when using vitros chemistry products phyt slide lot 2627- 0187-7864 on a vitros xt 7600 integrated system.The vitros qc results were compared to the center of the vitros tdm pv range of means.The assignable cause of the event was most likely a suboptimal phyt calibration.The cause of the suboptimal calibration was not determined.A recalibration was performed using an alternate calibrator kit lot and acceptable vitros tdm quality control results were obtained post calibration.The tsc requested pre-analytical handling of calibrators and control fluids.The ortho laboratory specialist indicated fluids were prepared fresh on the days of calibration and as per ortho recommendations for warmup and reconstitution.As the recalibration was performed with an alternate lot of calibrator fluids, an issue with calibrator kit lot 0952 could not be ruled out as a potential contributor to the event.In addition, it is not known if the same set of a new set of vitros tdm pv fluids was processed following the recalibration event.Therefore, an issue with the vitros tdm pv control fluids could have contributed to the event but this was not confirmed.There was no indication of an instrument issue.The phyt qc results were acceptable after recalibration with no other actions to the instrument itself indicating the vitros xt 7600 analyzer was not a likely contributor to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros chemistry products phyt slide lot 2627- 0187-7864.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros phyt quality control results were obtained from a vitros tdm iii pv qc fluid when using vitros chemistry products phyt slide lot 2627- 0187-7864 on a vitros xt 7600 integrated system.The vitros qc results were compared to the center of the vitros tdm pv range of means.Vitros tdm iii x1172 = 32.3, 32.4, 32.5 versus expected 26.2 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 non-reproducible, higher than expected vitros phyt quality control results were obtained from non-patient samples.There was no reported 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 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18928685
• Report Number: 1319808-2024-00008
• Device Sequence Number: 9445871
• Product Code: JIT
• UDI-Device Identifier: 10758750005031
• UDI-Public: 10758750005031
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2024

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: 01/17/2025
• Device Catalogue Number: 8568040
• Device Lot Number: 0952
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown