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

Model Number	6844508
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros k+ results were obtained from a single vitros calibrator kit 32 level 1 fluid, lot: 3222 using vitros k+ slide lot: 4102-0857-3923 on a vitros 5600 integrated chemistry system, which breached potential health and safety criteria.The assignable cause of the event was the calibrator 32, lot: 3222 level 1 fluid used to perform the calibration events.The calibrator level 1 average response was atypical when compared to the expected responses.Acceptable vitros k+ performance was obtained after calibrating with an alternate set of calibrator kit 32, lot: 3222 fluids.It is unknown what caused the performance issue with the calibrator kit 32, lot: 3222 level 1 fluid.A performance issue with the vitros k+ slide lots: 4102-1096-7827 and 4102-0857-3923 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.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros k+ results were obtained from a single vitros calibrator kit 32 level 1 fluid, lot: 3222 using vitros k+ slide lot: 4102-0857-3923 on a vitros 5600 integrated chemistry system, which breached potential health and safety criteria.Vitros calibrator kit 32, lot: 3222 level 1 vitros k+ results of 6.15 and 6.12 mmol/l vs.The vitros assigned value of 1.00 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.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4).

• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16600829
• Report Number: 0001319808-2023-00006
• Device Sequence Number: 12303323
• Product Code: JIX
• UDI-Device Identifier: 10758750032105
• UDI-Public: 10758750032105
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 03/22/2023

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: 08/08/2024
• Device Model Number: 6844508
• Device Catalogue Number: 6844508
• Device Lot Number: 3222
• 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: 02/24/2023
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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