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

Catalog Number	6844508
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros potassium (k+) results were obtained from a single level of non-vitros biorad multiqual unassayed controls, lot 56700, using vitros k+ slide lot 4102-1112-7951 and slide lot 4102-1129-8320 on a vitros 5600 integrated chemistry system.Vitros k+ slide lot 4102-1112-7951 biorad lot 56700 level 3 results of 4.17 and 4.08 mmol/l vs.The vitros peer mean of 7.79 mmol/l vitros k+ slide lot 4102-1129-8320 biorad lot 56700 level 3 results of 4.27 and 4.37 mmol/l vs.The vitros peer mean of 7.79 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.Patient samples were not affected and there were no allegations of harm as a result of this event.However, the investigation cannot conclude that patient sample results would not be affected at the same magnitude if the event were to recur undetected.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros potassium (k+) results were obtained from a single level of non-vitros biorad multiqual unassayed controls, lot 56700, using vitros k+ slide lot 4102-1112-7951 and slide lot 4102-1129-8320 on a vitros 5600 integrated chemistry system.The assignable cause of the event was the suboptimal calibrations in use at the time of the events.The affected calibration responses and parameters were atypical when compared to the expected responses and parameters.The affected calibrator kit in use was lot 3232.It is unknown what caused the performance issue with the affected calibrator kit 3232 calibrations.Calibrator 32 fluids are liquid, ready to use, therefore, a reconstitution issue was not the cause of the event.However, since both calibrations appeared atypical, it is possible that improper fluid sample handling or sample contamination prior to performing the calibrations was a potential cause of the event.Acceptable vitros k+ performance was obtained after calibrating each vitros k+ slide lot with an alternate set of calibrator kit 32, lot 3232 fluids.A performance issue with the vitros k+ slide lots 4102-1129-8320 and 4102-1112-7951 did not likely contribute to the event as acceptable vitros k+ performance was obtained after recalibrating with an alternate set of the same lot of calibrators.The investigation found no indication that either vitros 5600 integrated system contributed to the event.Acceptable vitros k+ performance was obtained after recalibrating with an alternate set of the same lot of calibrators, with no additional actions taken to optimize the vitros instruments.

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 32
• 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: 18855480
• Report Number: 1319808-2024-00006
• Device Sequence Number: 12835884
• 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): 03/06/2024

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 Catalogue Number: 6844508
• Device Lot Number: 3232
• 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: 02/10/2024
• Initial Report FDA Received Date: 03/07/2024
• 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