MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 5600 INTEGRATED SYSTEM-REFURBISHED; CLINICAL CHEMISTRY

Catalog Number	6802915
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros k+ results were obtained from a single level of a non-vitros thermofisher mas control (lot ocr2608) using vitros k+ slide lot 4102-1163-9277 on a vitros 5600 integrated system.The assignable cause of the event is suboptimal calibration due to user error, as the calibrator kit that the customer was using (cal kit 32) was not the calibrator kit that the vitros 5600 integrated system was configured for (cal kit 2) at the time of the calibration events.An ortho field application specialist (fas) arrived onsite and identified this issue.The ortho fas reconstituted fresh calibrator kit 2 (of which the analyzer was configured to use) and recalibrated the vitros k+ slide lot 4102-1163-9277.The calibration data and post-calibration qc were acceptable.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros k+ results were obtained from a single level of a non-vitros thermofisher mas control (lot ocr2608) using vitros k+ slide lot 4102-1163-9277 on a vitros 5600 integrated system.Vitros k+ slide lot 4102-1163-9277 mas ocr2608 l1 results of 3.73, 3.82, 3.78, 3.81, 3.89, 3.72, and 3.69 mmol/l vs.The expected result of 2.65 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 a non-patient quality control sample, however, the investigation cannot conclude that patient sample results were not or would not be affected if the event were to recur undetected.There were no reported 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 5600 INTEGRATED SYSTEM-REFURBISHED
• Common Device Name: CLINICAL CHEMISTRY
• 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: 22854167
• Report Number: 1319681-2025-00037
• Device Sequence Number: 18257236
• Product Code: JJE
• UDI-Device Identifier: 10758750002740
• UDI-Public: (01)10758750002740
• 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
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: 6802915
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2019
• 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