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

Catalog Number	8157596
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected potassium (k+) result was obtained from a patient sample processed during correlation testing using vitros chemistry products k+ slides lot 4102-1162-9602 on a vitros 350 chemistry system.The vitros result for the sample was discordant when compared to the result obtained from the same sample using a non-vitros exias method.Patient sample vitros k+ result of 3.8 mmol/l vs the expected result of 6.69 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros k+ result was obtained during a method to method correlation test and was not reported from 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 612044.
Additional Manufacturer Narrative
The investigation has determined that a lower than expected potassium (k+) result was obtained from a patient sample processed during correlation testing using vitros chemistry products k+ slides lot 4102-1162-9602 on a vitros 350 chemistry system.The vitros result for the sample was discordant when compared to the result obtained from the same sample using a non-vitros exias method.The investigation could not determine a definitive assignable cause of the event.Based on historical quality control results, a vitros k+ lot 4102-1162-9602 performance issue is not a likely contributor of the event.However, an individual slide related issue could not be entirely ruled out.As no precision testing was performed on the vitros 350 system, an instrument related issue cannot be entirely ruled out as a contributing factor of the event.However, an instrument related issue is not a likely contributor to the event as historical qc results were precise and acceptable results were obtained from other patient samples processed on the vitros instrument during the initial correlation testing.Pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not following the sample collection device manufacturer's recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros k+ lot 4102-1162-9602.

• 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 23089659
• Report Number: 1319809-2025-00079
• Device Sequence Number: 18559708
• Product Code: CEM
• UDI-Device Identifier: 10758750010233
• UDI-Public: (01)10758750010233(17)260601(11)241226(10)410211629602
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

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 Expiration Date: 06/01/2026
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1162-9602
• 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: 06/23/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2024
• 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