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	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher-than-expected calcium (ca) result was obtained from a non-vitros biorad quality control fluid using vitros chemistry products ca slides lot 0356-0683-4072 on a vitros 5600 integrated system.Biorad lot 45960 level 1 result of 9.64 mg/dl vs.The expected result of 5.85 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 ca result was obtained from a quality control fluid and no results were reported from the laboratory.No patient samples had been processed using the vitros ca reagent lot.There have been 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).
Additional Manufacturer Narrative
The investigation has determined that a higher than expected calcium (ca) result was obtained from a non-vitros biorad quality control fluid using vitros chemistry products ca slides lot 0356-0683-4072 on a vitros 5600 integrated system.The assignable cause of the higher than expected vitros ca quality control result is a suboptimal calibration.The slope and intercept values of the initial calibration from the day of the event for vitros ca reagent lot 0356-0683-4072 were abnormally high compared to the release values.After the reagent was recalibrated the parameters of that calibration were determined to be typical.The quality control results processed after the recalibration event were deemed acceptable.The cause of the suboptimal calibration is improper protocol by the customer related to the preparation of vitros cal kit 1 lot 0183.The customer confirmed that the operator had used 5ml of diluent when reconstituting the vitros calibrator kit 1 fluids.The instructions for use for vitros cal kit 1 recommends using either a class a volumetric pipette or an automated pipette due to the sensitivity of the reconstitution process in maintaining the accuracy of the products and states to use 3ml of diluent when reconstituting the vials of cal kit 1.Recalibration with freshly prepped calibrator fluids following the correct protocol resolved the issue as post calibration qc results were within expectations.

• 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: 20785685
• Report Number: 1319808-2024-00045
• Device Sequence Number: 15711535
• Product Code: JIX
• UDI-Device Identifier: 10758750000166
• UDI-Public: (01)10758750000166(17)251030(11)231030(10)0183
• 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): 11/25/2024

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: 10/30/2025
• Device Catalogue Number: 1882208
• Device Lot Number: 0183
• 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: 11/04/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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