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

Catalog Number	6844461
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros alcohol (alc) results were obtained from a vitros creatinine kinase (ck) slide cartridge on a vitros xt 7600 integrated system.The assignable cause of the event is user error.The vitros operator loaded a vitros ck cartridge into slot 12 and the supply was scanned, however slot 12 did not show a barcode or an error reading the barcode.The vitros inventory manager registered that slot 12 was empty and the vitros ck cartridge was not inventoried.The operator of the vitros xt7600 system performed a manual load of a vitros alc cartridge, and when the slide supply load door presented slot 12 with what was registered as an empty slot, a vitros ck cartridge was already in the slot.The operator placed the vitros ck cartridge back into the supply in the same slot and then closed the door, which led the vitros inventory manager to interpret that the vitros alc slide cartridge had been manually loaded when it was not.Vdocs (onboard documentation) has this precaution for manual slide cartridge loading: -open the load door for the appropriate slide supply.If there is a slide cartridge in the slot, remove the cartridge.If the cartridge that you have removed is empty, discard the cartridge.If the cartridge contains microslides that can still be used on the system, load this cartridge in a later reagent management load session.Warning: during the manual load process, once you open the slide supply door, you must place the cartridge that you have identified in the "manually load cart" dialog into the presented slide supply slot.Failure to do so may result in tests being performed with slides from an incorrect cartridge, potentially leading to wrong patient results.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report that higher than expected vitros alcohol (alc) results were obtained on two samples from the same patient and a quality control fluid using a vitros creatinine kinase (ck) slide cartridge that was misidentified as a vitros alc slide cartridge on a vitros xt 7600 integrated system.Patient sample 1: alc = >300 mg/dl, >600 mg/dl with 2x dilution patient sample 2: alc = >300 mg/dl, >600 mg/dl with 2x dilution biorad level 1: alc = >300 mg/dl versus baseline mean 48.2 mg/dl biorad level 2: alc = >300 mg/dl versus baseline mean 145.2 mg/dl assay results obtained from a slide cartridge (ck) other than the intended slide cartridge (alc) may lead to inappropriate physician action.The higher-than-expected vitros alc patient results were reported from the laboratory; however, a corrected report was later issued with a repeat vitros alc result of <10 mg/dl.The patient was admitted based on the higher-than-expected results; however.No treatment was stopped, started or altered during this timeframe and the patient was released upon the repeat testing.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).

• 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 23839425
• Report Number: 1319681-2025-00059
• Device Sequence Number: 13251480
• Product Code: JJE
• UDI-Device Identifier: 10758750031610
• UDI-Public: (01)10758750031610
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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 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: 11/26/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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