MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS K+ SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number	8157596
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
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 potassium (k+) results were obtained from a single patient sample using vitros k+ lot 4102-1194-8274 tested on a vitros xt 7600 integrated system.Vitros k+ patient sample results of 3.5, 4.8, 3.6, 5.0, 3.7 mmol/l vs.The expected result of 2.9 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher-than-expected patient sample results were obtained from a single patient sample and were not reported outside of the laboratory.There was no allegation 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 potassium (k+) results were obtained from a single patient sample using vitros k+ lot 4102-1194-8274 tested on a vitros xt 7600 integrated system.The assignable cause of the event is unknown.Historical vitros k+ lot 4102-1194-8274 quality control results were within expectation, and precision testing using this lot with performance verifier fluids was within ortho acceptable guidelines, indicating a reagent related issue is not a likely contributor to the event.Additionally, continual tracking and trending does not indicate a systemic issue with vitros k+ lot 4102-1194-8274.Although the customer did not process diagnostic precision testing on the vitros xt7600 system, an issue with the analyzer is not a likely contributor to the event based on acceptable historical qc and acceptable pv results from the vitros k+ precision testing.Pre-analytical sample processing could not be entirely ruled out as a contributing factor as the customer is not following the device manufacturers protocol for sample preparation.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.

• Brand Name: VITROS CHEMISTRY PRODUCTS K+ SLIDES
• 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.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24251687
• Report Number: 1319809-2026-00004
• Device Sequence Number: 13254399
• Product Code: CEM
• UDI-Device Identifier: 10758750010233
• UDI-Public: (01)10758750010233(17)270301(11)250922(10)410211948274
• 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): 02/03/2026

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: 8157596
• Device Lot Number: 4102-1194-8274
• 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: 01/06/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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