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

Catalog Number	1662659
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros sodium (na+) results were obtained from a single level of a non-vitros biorad control (lot 46020) using vitros na+ slide lot 4284-1177-7102 on a vitros xt 7600 integrated system.The assignable cause of the event is a suboptimal calibration.The calibration slope and intercept parameters appeared suboptimal when compared to expected calibration parameters and the biorad quality control results obtained post calibration were unacceptable.The cause of the suboptimal calibration remains unknown.The customer confirmed that they were following manufacturer guidelines for cal kit 2 storage and preparation.Therefore, improper cal kit storage and/or protocol is not a likely contributor to the event.The customer recalibrated using vitros calibrator kit 32 (lot 3285) on 27 january 2026.This calibrator kit comes liquid ready to use.The calibration data appeared typical to vitros release and peer calibration data, and post-calibration biorad qc results were within acceptable range.In addition, an acceptable patient correlation verified patient accuracy using vitros na+ slide lot 4284-1177-7102.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros sodium (na+) results were obtained from a single level of a non-vitros biorad control (lot 46020) using vitros na+ slide lot 4284-1177-7102 on a vitros xt 7600 integrated system.Biorad 46020 level 3 results of 143.0 and 144.0 mmol/l vs.The expected result of 164.6 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 lower-than-expected results were obtained from a non-patient quality control sample.There were no reported 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: 24403437
• Report Number: 1319808-2026-00008
• Device Sequence Number: 15917373
• 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): 02/20/2026

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: 01/26/2026
• Initial Report FDA Received Date: 02/20/2026
• 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