MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2; IN-VITRO DIAGNOSTICS

Catalog Number	1662659
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that higher than expected results were obtained from a non-vitros mas quality control using vitros chemistry products: potassium (k+) slides lot 4102-0965-8156 and vitros chemistry products sodium (na+) slides lot 4208-1180-8532 processed on a vitros 5600 integrated system.The assignable cause of the higher-than-expected vitros k+ and na+ results is suboptimal calibrations.The parameters for the calibrations used at the time of the event were determined to be suboptimal compared to the database values.The cause of the suboptimal calibrations is unknown.An issue related to the preparing and handling of the vitros cal kit 2 fluids cannot be entirely ruled out as a contributor of the suboptimal calibrations.Following a recalibration event using freshly prepared vitros cal kit 2 lot 0224 fluids, qc results using the mas controls returned to expectations for both vitros na+ and k+.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected results were obtained from a non-vitros mas quality control using vitros chemistry products: potassium (k+) slides lot 4102-0965-8156 and vitros chemistry products sodium (na+) slides lot 4208-1180-8532 processed on a vitros 5600 integrated system.Vitros na+ mas lot ocr2704 level 1 results of 187.1 and 187.6 mmol/l vs an expected result of 118.0 mmol/l vitros k+ mas lot ocr2704 level 1 result of 4.29 mmol/l vs an expected result of 2.65 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.The higher-than-expected results were obtained from quality control fluids and no results were reported from the laboratory.The customer confirmed that no patient samples were processed after the unacceptable qc results were obtained.There have been 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 2
• 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24470101
• Report Number: 1319808-2026-00011
• Device Sequence Number: 18711452
• Product Code: JIX
• UDI-Device Identifier: 10758750009503
• UDI-Public: (01)10758750009503(17)261223(11)241223(10)0224
• 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): 02/27/2026

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: 1662659
• Device Lot Number: 0224
• 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: 01/30/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• 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