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

Catalog Number	1450261
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a lower than expected vitros calcium (ca) result was obtained from a single quality control level processed on a vitros xt 7600 integrated system.A definitive assignable cause could not be determined.A possible cause of this event could be a non-reactive cartridge, where the integrity of the foil wrapper was compromised during shipment or storage on site, exposing the slides to ambient conditions, though this could not be verified.The lower than expected vitros ca result was isolated to a single slide cartridge.The event is consistent with a slide cartridge that has been exposed to ambient conditions.Acceptable vitros ca results were obtained from an alternate slide cartridge from the same slide lot.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected vitros calcium (ca) result was obtained from a single quality control level processed on a vitros xt 7600 integrated system.Biorad multiqual level 3 lot 56760 result of 7.8 mg/dl vs the expected result of 12.22 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.Twenty-four patient samples were processed during the timeframe of the event and generated negatively biased vitros ca results.None of the negatively biased results were reported outside of the laboratory.All 24 samples were retested using a slide cartridge other than the affected cartridge, and the customer considered the repeat results to be the expected results for the samples.The customer did not provide any specific data concerning the 24 affected samples.There were no 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).

• Brand Name: VITROS CHEMISTRY PRODUCTS CA 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: 23015562
• Report Number: 1319809-2025-00075
• Device Sequence Number: 18598181
• Product Code: CJY
• UDI-Device Identifier: 10758750009114
• UDI-Public: (01)10758750009114(17)260201(11)240831(10)035906855681
• 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): 09/09/2025

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: 1450261
• Device Lot Number: 0359-0685-568
• 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: 08/14/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2024
• 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