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

Catalog Number	8379034
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher-than-expected vitros na+ result was obtained from a single level of non-vitros thermofisher mas omnicore (mas) control, lot ocr2608, using vitros sodium (na+) slide lot 4273-1155-1024 on a vitros 4600 chemistry system.Mas l1 na+ result of 136.6 mmol/l vs.The expected result of 121.1 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 non-patient sample quality control samples.However, the investigation could not rule out that patient samples were not or would not be affected if the event occurred undetected.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 a higher than expected vitros na+ result was obtained from a single level of non-vitros thermofisher mas omnicore (mas) control, lot ocr2608, using vitros sodium (na+) slide lot 4273-1155-1024 on a vitros 4600 chemistry system.The assignable cause of the issue could not be determined.A suboptimal calibration due to improper calibrator sample handling cannot be ruled out as contributing to the event.The customer was using the reconstituted calibrators as soon as the diluent was added.The ortho cal kit 2 instructions for use states that once the diluent is added, reconstitution, with occasional inversion, may take up to 30 minutes.The customer is not following ortho specifications for calibrator reconstitution.Pre-analytical sample mix-up could not be ruled out as contributing to the event.The mas l1 results was similar to the mas l2 results previously obtained from the same calibration event.However, the customer denied this occurred, so pre-analytical sample mix-up could neither be ruled out or confirmed.A diagnostic vitros na+ within-run precision test, which is used to assess analyzer performance, had precision results within the acceptance criterion, indicating an analyzer performance issue did not likely contribute to the event.Historical quality control results were unacceptable using vitros na+ slide lot 4273-1155-1024, therefore, a reagent related performance issue cannot be ruled out as contributing to the event.

• Brand Name: VITROS CHEMISTRY PRODUCTS NA+ 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: 22648115
• Report Number: 1319809-2025-00060
• Device Sequence Number: 8769497
• Product Code: JGS
• UDI-Device Identifier: 10758750004812
• UDI-Public: (01)10758750004812(17)260201(11)240813(10)427311551024
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 07/28/2025

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: 02/01/2026
• Device Catalogue Number: 8379034
• Device Lot Number: 4273-1155-1024
• 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: 07/08/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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