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

Catalog Number	8379034
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a lower-than-expected vitros sodium (na+) result was obtained from a single patient sample tested on vitros 5600 integrated system, compared to repeat testing from the same patient sample.A definitive assignable cause could not be determined.The customer only provided quality control results from the date of the event, which was within the established control ranges, however, there were insufficient data points to fully assess the total performance of vitros na+ slide lot: 4280-1161-2591.Therefore, a vitros na+ slide lot: 4280-1161-2591 performance issue cannot be completely ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros na+ slide lot: 4280-1161-2591.A performance issue with the vitros 5600 integrated system did not likely contribute to the event as a diagnostic vitros na+ within-run precision test was within the acceptance criterion indicating the vitros 5600 integrated system was performing as intended.It is unknown if the customer was following the collection device manufacturer's specifications for centrifugation, therefore, improper pre-analytical sample processing could not be ruled out as contributing to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower-than-expected vitros sodium (na+) result was obtained from a single patient sample tested on vitros 5600 integrated system, compared to repeat testing from the same patient sample.Patient (b)(6) sample vitros na+ result of 108.0 mmol/l vs.The repeat result of 153.1 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 na+ result was not reported from the laboratory and there allegation of harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4).

• 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: 23015483
• Report Number: 1319809-2025-00076
• Device Sequence Number: 15837563
• Product Code: JGS
• UDI-Device Identifier: 10758750004812
• UDI-Public: (01)10758750004812(17)260901(11)250329(10)428011612591
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/10/2025

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: 09/01/2026
• Device Catalogue Number: 8379034
• Device Lot Number: 4280-1161-2591
• 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: 08/13/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2025
• 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