MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS XT 7600 INTEGRATED SYSTEM; CHEMISTRY ANALYZER

Catalog Number	6844461
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report multiple patient and quality control samples were tested with a vitros ca slide cartridge that was mis-identified as a vitros altv slide cartridge on a vitros xt 7600 integrated system.Vitros pv i, lot e2828 results of 45.7, 45.2 and 44.9 u/l vs.The range of means midpoint value of 121.4 u/l vitros pv ii, lot d2338 results of 280.3, 280.7 and 277.7 u/l vs.The range of means midpoint value of 138.7 u/l patient sample results were not listed as the customer did not provide the expected results.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The ortho tsc made multiple follow up attempts with the customer to determine if the affected patient sample results were reported outside of the laboratory, and if the samples were retested and if correct reports were issued.The customer has not yet provided the requested information after multiple attempts by the ortho tsc to obtain the information.There has been 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 multiple patient and quality control samples were tested with a vitros calcium (ca) slide cartridge that was mis-identified as a vitros altv slide cartridge on a vitros xt7600 integrated system.The assignable cause of this event is user error while manually loading a vitros slide cartridge.The vitros xt 7600 integrated system hardware and software were operating as expected.A total of 24 patient samples and 6 vitros performance verifier (pv) results were processed on the vitros ca slide cartridge mis-identified as an altv slide cartridge and erroneous altv results were obtained.

• Brand Name: VITROS XT 7600 INTEGRATED SYSTEM
• Common Device Name: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 22969383
• Report Number: 1319681-2025-00041
• Device Sequence Number: 9007473
• Product Code: JJE
• UDI-Device Identifier: 10758750031610
• UDI-Public: (01)10758750031610
• 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): 09/04/2025

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 Catalogue Number: 6844461
• 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: 08/08/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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