MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2; IN-VITRO DIAGNOSTICS

Catalog Number	1662659
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros sodium (na+) results were obtained from a single level of biorad unassayed control lot 92950 using vitros na+ slide lot 4231-1117-4978 on a vitros 5600 integrated system.Biorad lot 92950 level 1 results of 134.0 and 133.5 mmol/l vs.The expected result of 156.0 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.The lower than expected results were obtained from a non-patient quality control sample, however, multiple unknown samples that may have been patient samples were processed in the timeframe of the event.The customer did not report any 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 determined that lower than expected vitros sodium (na+) results were obtained from a single level of biorad unassayed control lot 92950 using vitros na+ slide lot 4231-1117-4978 on a vitros 5600 integrated system.The assignable cause of the event is a suboptimal calibration.The event started with a calibration event that occurred on (b)(6) 2024.The calibration responses and parameters appeared atypical to expected responses and parameters.Atypical vitros na+ results were obtained from a calibration generated using calibrator kit lot 0272.Therefore, a performance issue with the calibrator kit lot 0272 fluids in use at the site could not be completely ruled out as contributing to the event.Calibrator kit 2 requires reconstitution and consists of lyophilized vials for each calibrator level with corresponding diluent vials for each calibrator level.It is possible that improper pre-analytical fluid handling or reconstitution contributed to the event however, this cannot be confirmed.Historical quality control results obtained from vitros na+ slide lot 4231-1117-4978 using the previous two calibrations and a following calibration were within established control ranges, indicating the vitros na+ slides were performing as intended on the vitros 5600 integrated system.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros na+ slide lot 4231-1117-4978.Acceptable performance was obtained after recalibrating vitros na+ slide lot 4231-1117-4978 with cal kit 3222.

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1000 lee road; rochester NY 14606
• 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: 18807640
• Report Number: 1319808-2024-00005
• Device Sequence Number: 15239742
• Product Code: JIX
• UDI-Device Identifier: 10758750009503
• UDI-Public: 10758750009503
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2024

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: 10/10/2024
• Device Catalogue Number: 1662659
• Device Lot Number: 0272
• 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: 02/04/2024
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown