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	05/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros calcium (ca+) and vitros glu results obtained from two levels of non-vitros biorad quality control (qc) fluid (lot 46050) using vitros xt chemistry products glu-ca microslides, lot 7427-0024-4218 on a vitros xt 3400 chemistry system.The results were higher than expected when compared to customer baseline mean values.Vitros xt chemistry products glu-ca microslides, lot 7427-0024-4218: biorad lot 46050 l1 vitros ca results of 8.94, 8.68, 8.83, and 8.71 mg/dl vs the baseline mean of 5.85 mg/dl.Biorad lot 46050 l1 vitros glu results of 535.6, 538.6, 530.8, 546.4, and 530.6 mg/dl vs the baseline mean of 353.0 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+ and glu results were obtained from a quality control fluid and no results were reported from the laboratory.There has been no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4), (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros calcium (ca+) and vitros glu results were obtained from two levels of non-vitros biorad quality control (qc) fluid (lot 46050) using vitros xt chemistry products glu-ca microslides, lot 7427-0024-4218 on a vitros xt 3400 chemistry system.The results were higher than expected when compared to customer baseline mean values.The assignable cause of the event is a suboptimal calibration event.The cause of the suboptimal calibration event remains unknown.The calibration data for the affected calibration events on (b)(6) 2026 demonstrate atypical data when compared to peer data and all post-calibration qc results for both vitros ca+ and vitros glu assays were positively biased outside baseline and peer (vitros ca+) and package insert (glu) ranges, demonstrating atypical calibration events.A recalibration event using fresh calibrator kit (cal kit) 1 fluid was performed and acceptable post-calibration qc was observed, verifying resolution of the issue.

• 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 25470427
• Report Number: 1319808-2026-00032
• Device Sequence Number: 21439051
• 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): 06/10/2026

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: 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: 05/16/2026
• Initial Report FDA Received Date: 06/11/2026
• 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