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	04/17/2026
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 sodium (na+) slide lot 4213-1185-0237 and vitros potassium (k+) slide lot 4102-1197-9201 results were obtained from a single level of non-vitros biorad multiqual assayed lot 46030 controls tested on a vitros xt7600 integrated system.Biorad level 1 na+ results of 193.5, 192.8, 191.1, 195.3 and 194.9 mmol/l vs.The expected result of 114.99 mmol/l biorad level 1 k+ results of 4.48, 4.49, 4.48, 4.54 and 4.55 mmol/l vs.The expected result of 2.58 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 a non-patient quality control sample, however, unknown samples that may have been patient samples were processed in the timeframe of the event.There was 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).
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros sodium (na+) slide lot 4213-1185-0237 and vitros potassium (k+) slide lot 4102-1197-9201 results were obtained from a single level of non-vitros biorad multiqual assayed lot 46030 controls tested on a vitros xt7600 integrated system.The assignable cause of the higher than expected vitros na+ and k+ results was user error, where five atypical calibrations were generated from vitros calibrator lot 0235 fluids that were improperly reconstituted.No details were provided concerning the improper reconstitution.Expected vitros na+ and k+ results were obtained after calibrating with an alternate set of vitros calibrator kit lot 0235 fluids that were properly reconstituted.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with either vitros na+ slide lot 4213-1185-0237 and vitros k+ slide lot 4102-1197-9201.No diagnostic within-run precision testing was performed to assess the performance of the vitros xt7600 integrated system, therefore, an instrument related performance issue cannot be ruled out as contributing to the event.

• 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: 25162988
• Report Number: 1319808-2026-00023
• Device Sequence Number: 8660594
• Product Code: JIX
• UDI-Device Identifier: 10758750009503
• UDI-Public: (01)10758750009503(17)270915(11)250915(10)0235
• 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): 05/13/2026

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: 0235
• 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: 04/18/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• 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