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	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros crea result was obtained from vitros performance verifier (pv) i using vitros creatinine (crea) slide lot 1515-3568-9503 tested on a vitros 250 chemistry system.The assignable cause of the event was a suboptimal calibration event most likely caused by user error.The customer performed the calibration using a set of vitros calibrator kit 1, lot 0114 that was previously reconstituted and stored refrigerated.It is unknown on what date the vitros calibrator kit 1, lot 0114 fluids were reconstituted, or long they were stored in the refrigerator.The vitros calibrator kit 1 instructions for use states the calibrators should be used within 24 hours after reconstitution.Acceptable vitros crea performance was obtained using an alternate calibration event that was generated using a new set of vitros calibrator kit 0114 that were reconstituted and used the same day.This indicated neither vitros crea slide lot 1515-3568-9503 nor the vitros 250 chemistry system likely contributed to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros crea slide lot 1515-3568-9503.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher-than-expected vitros crea result was obtained from vitros performance verifier (pv) i using vitros creatinine (crea) slide lot 1515-3568-9503 tested on a vitros 250 chemistry system.Vitros pv i lot b2245 vitros crea result of 1.63 mg/dl vs.The vitros range of mean midpoint peer value of 1.03 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 crea result was obtained from a non-patient quality control fluid, however, the investigation could not rule out that patient samples would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 611162.

• 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: 22381986
• Report Number: 1319808-2025-00025
• Device Sequence Number: 18500787
• Product Code: JIX
• UDI-Device Identifier: 10758750000166
• UDI-Public: (01)10758750000166(17)261007(11)241007(10)0114
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 07/02/2025

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: 1882208
• Device Lot Number: 0114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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