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	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected results were obtained from vitros calcium (ca) slide lot 0359-0685-5671 from a single level of non-thermofisher mas omnicore (mas) controls, lot ocr2608 tested on a vitros 5600 integrated system.The investigation did not determine the assignable cause of the event.An ortho field application specialist observed the customer was using improper fluid and reagent handling protocols prior during the timeframe of the event; therefore, improper reagent and fluid handling protocol cannot be ruled out as contributing to the event.The customer was reconstituting calibrators with 3 ml of diluent using a 1 ml pipette where 1 ml of diluent was aspirated/dispensed three times, which is not good laboratory practice.The ortho fas referred the customer to the calibrator kit 1 instructions for use, that states a 3 ml volumetric pipette should be used to reconstitute the calibrators.In addition, the customer was not changing the dropper tip with each new quality control vial in use, for all three levels.Proper protocol is to use a new dropper tip with each new vial of control used.The ortho fas stated the dropper tips in use had visible staining and dried quality control material on the tips.Historical vitros ca lot 0359-0685-5671 quality control results were imprecise, indicating that this lot was not performing as expected leading up to the event.However, a performance issue with vitros ca slide lot 0359-0685-5671 did not likely contribute to the event as the vitros altv and uric assays were also affected and it is unlikely there were performance issue with three different vitros microslide assays.Additionally, continual tracking and trending did not indicate a systemic performance issue with vitros ca lot 0359-0685-5671.No diagnostic within-run precision testing to assess the performance the vitros 5600 integrated system was performed, however, since historical quality control results were acceptable, it is not likely an instrument related performance issue contributed to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected results were obtained from vitros calcium (ca) slide lot 0359-0685-5671 from a single level of non-thermofisher mas omnicore (mas) controls, lot ocr2608 tested on a vitros 5600 integrated system.Mas level 3 vitros ca results of 9.49, 9.44, 9.44, 9.69, 9.39 and 6.14 mg/dl vs.The expected result of 12.20 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected vitros ca results were obtained from a non-patient quality control fluid.There was no allegation of harm as a result of this event.This report is number six of six mdrs for this event.Six 3500a forms are being submitted for this event as six devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 608996.

• 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: 21468322
• Report Number: 1319809-2025-00019
• Device Sequence Number: 8658895
• Product Code: CJY
• UDI-Device Identifier: 10758750009114
• UDI-Public: (01)10758750009114(17)260201(11)240826(10)035906855671
• 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): 02/25/2025

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: 0359-0685-5671
• 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: 01/30/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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