MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN-VITRO DIAGNOSTICS

Catalog Number	1882208
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
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 glucose (glu) results were obtained from a single level of non-vitros biorad multiqual lot 46010 control tested on a vitros 5600 integrated system.Biorad multiqual lot 46010 level 3 vitros glu results of 613.2, 612.2, 614.3, 613.3, 611.5, 611.4 and 612.5 mg/dl vs.The expected result of 344.21 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 higher-than-expected vitros glu results were obtained from non-patient quality control samples.There was no allegation of patient harm as a result of this event.This report is number two of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.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 higher than expected vitros glucose (glu) results were obtained from a single level of non-vitros biorad multiqual lot 46010 control tested on a vitros 5600 integrated system.The assignable cause of the event was two suboptimal calibrations.Calibration responses and parameters from the two affected calibrations were atypical when compared to expected responses and parameters.The cause of the suboptimal calibrations was not determined.Acceptable performance was obtained from a calibration using an alternate set of the same lot of calibrators with calibration responses and parameters that were typical when compared to expected responses and parameters.A performance issue with the vitros 5600 integrated system did not likely contribute to the event as acceptable performance was obtained using a calibration with typical responses and parameters, without taking any actions to optimize the vitros 5600 integrated system.A vitros glu slide lot 0042-3250-7823 performance issue cannot be completely ruled out as slight within-lab imprecision was observed prior to the event; however, the magnitude of the imprecision would not have caused the magnitude of bias observed with the results meeting potential health and safety criteria.

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
• 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: 21886627
• Report Number: 1319808-2025-00020
• Device Sequence Number: 3442556
• Product Code: JIX
• UDI-Device Identifier: 10758750000166
• UDI-Public: (01)10758750000166(17)260429(11)240429(10)0194
• 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): 04/22/2025

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: 04/29/2026
• Device Catalogue Number: 1882208
• Device Lot Number: 0194
• 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: 03/25/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2024
• 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