MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 32; IN-VITRO DIAGNOSTICS

Catalog Number	6844508
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros sodium (na+) results were obtained from a single level of non-vitros mas level 1 quality control fluid, lot: ocr2608, using vitros na+ slide lot: 4261-1141-5763 on a vitros 5600 integrated system.Mas level 2 na+ results of 197.6 and 200.7 mmol/l vs.The expected result of 121.1 mmol/l biased results of the magnitude and direction observed may led to inappropriate physician action if they were to occur undetected on patient samples.Patient samples were not affected and there were no allegations of harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4).
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros sodium (na+) results were obtained from a single level of non-vitros mas level 1 quality control fluid, lot: ocr2608, using vitros na+ slide lot: 4261-1141-5763 on a vitros 5600 integrated system.The assignable cause of the event was a suboptimal calibration.The cause of the suboptimal calibration is unknown.Acceptable vitros na+ performance was observed after restoring a previously acceptable calibration, as well as on another subsequent calibration.Historical vitros na+ lot: 4261-1141-5763 quality control results were within expectation for level 1 but slightly imprecise for level 2, however the magnitude of the level 2 precision would not cause the bias observed from the unexpected quality control results.The investigation found no indication the vitros 5600 integrated system or vitros na+ slide lot: 4261-1141-5763 malfunctioned, as restoring a previous calibration without any additional actions resolved the issue.Additionally, the customer processed a diagnostic vitros na+ precision test using their non-vitros mas l2 quality control fluid, which was within ortho acceptable guidelines, further verifying acceptable vitros 5600 system performance.Continual tracking and trending does not indicate a systemic issue with vitros na+ lot: 4261-1141-5763.

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 32
• 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.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21286708
• Report Number: 1319808-2025-00006
• Device Sequence Number: 13144130
• Product Code: JIX
• UDI-Device Identifier: 10758750032105
• UDI-Public: (01)10758750032105(17)260923(11)240923(10)3264
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/31/2025

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: 09/23/2026
• Device Catalogue Number: 6844508
• Device Lot Number: 3264
• 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: 01/06/2025
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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