MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN-VITRO DIAGNOSTICS

Catalog Number	1882208
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined higher than expected calcium results were obtained from quality control (qc) fluids processed using vitros calcium (ca) slide lot: 0369-0700-8801 on a vitros 5600 integrated system.The investigation concluded that the assignable cause was suboptimal calibrations.The cause of the suboptimal calibrations was most likely user error.The customer recalibrated the current vitros ca slide lot after loading a new slide cartridge.The qc had already been processed that morning and acceptable results were obtained.The lead tech suspected the operator thought they had to recalibrate when loading a new slide cartridge.The operator was a new employee and not trained on vitros yet.A review of calibration parameters concluded that they were suboptimal with a significantly high slope when compared to release and average slopes for e-connected analyzers.The new, untrained operator reconstituted the calibrator fluids and it cannot be confirmed if they used the 1ml pipette or 3ml pipette to reconstitute the fluids.Per calibrator kit 1 instructions for use add 3.0 ml of the appropriate diluent to each vial.Use a clean, dry pipette for each vial.A class a volumetric pipette or an automated pipette of equivalent accuracy is recommended because of the importance of this reconstitution procedure to the accuracy of the results.Discard any remaining diluent.The customer restored the previously acceptable vitros ca lot: 0369-0700-8801 calibration that was in use prior to the day of the event.All three levels of mas omni core qc results obtained using that previous calibration were acceptable and the customer agreed to use that calibration moving forward.It is likely that improper preparation of the calibrator fluids caused suboptimal calibrations and higher than expected vitros ca results.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected calcium results were obtained from quality control (qc) fluids processed using vitros calcium (ca) slide lot: 0369-0700-8801 on a vitros 5600 integrated system.Mas omni core (lot: ocr2608) level 1 = 12.99, 12.78, 12.34, 12.11 versus baseline mean 6.82 mg/dl 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 ca results were obtained from quality control fluids.However, the investigation cannot conclude that patient results would not be affected if the event were to recur undetected.There were no allegations 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 1
• 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: 22642103
• Report Number: 1319808-2025-00027
• Device Sequence Number: 20996230
• Product Code: JIX
• UDI-Device Identifier: 10758750000166
• UDI-Public: (01)10758750000166(17)261209(11)241209(10)0124
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

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 Catalogue Number: 1882208
• Device Lot Number: 0124
• 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: 07/07/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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