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

Catalog Number	6844508
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected vitros sodium (na+) result was obtained from a single non-vitros biorad level 2 quality control fluid, lot 92952, using vitros na+ slide lot 4254-1134-2426 on a vitros xt 3400 chemistry system.Biorad level 2 na+ result of 106.9 mmol/l vs.The expected result of 157.4 mmol/l biased results of the magnitude and direction observed may lead 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) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that a lower than expected vitros sodium (na+) result was obtained from a single non-vitros biorad level 2 quality control fluid, lot 92952, using vitros na+ slide lot 4254-1134-2426 on a vitros xt 3400 chemistry system.The event was isolated to the calibration event performed on 19 september 2024 (cal id 2949).The calibration was suboptimal when compared to the peer calibration parameters, and as shown by the low recovery of the post calibration quality control results.The assignable cause of the suboptimal 19 september calibration is the user calibration with the incorrect order of the calibrator bottles (user error), as supported by the "u90-353: calibration bottles out of order id" mechanical error code that posted during the calibration event.Acceptable vitros na+ performance was observed after restoring acceptable cal id 2911.The investigation found no indication the vitros xt 3400 chemistry system or vitros na+ slide lot 4254-1134-2426 malfunctioned, as restoring a previous calibration without any additional actions resolved the issue.

• 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: 20481863
• Report Number: 1319808-2024-00038
• Device Sequence Number: 8266862
• Product Code: JIX
• UDI-Device Identifier: 10758750032105
• UDI-Public: (01)10758750032105(17)250123(11)230123(10)3232
• 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): 10/16/2024

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: 01/23/2025
• Device Catalogue Number: 6844508
• Device Lot Number: 3232
• 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: 09/19/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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