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

Catalog Number	6844508
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
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 potassium (k+) results were obtained when processing biorad multiqual qc lot 56690 after the calibration of two vitros k+ slide lots using the same set of calibrator fluids.Vitros chemistry products k+ slides, lot 4102-1111-5623 calibration curve 4365 vitros k+ result >14 mmol/l versus biorad peer mean 2.64 mmol/l vitros chemistry products k+ slides, lot 4102-1089-3607 calibration curve 4362 vitros k+ results >14, >14, >14, >14, and >14 mmol/l versus biorad peer mean 2.64 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 higher than expected vitros k+ results were obtained from a quality control fluid and were not reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation concludes that higher than expected potassium (k+) results were obtained when processing biorad multiqual qc lot 56690 after the calibration of two vitros k+ slide lots using the same set of calibrator fluids.The likely cause of the higher than expected vitros k+ results is an unknown issue with a single set of vitros calibrator kit 32 lot 3222 fluids used for calibrating the two vitros k+ slide lots resulting in suboptimal calibrations.A recalibration of vitros k+ slide lots 4102-1111-5623 and lot 4102-1089-3607 was performed using a fresh set of vitros calibrator kit 32 fluids and acceptable quality control results were obtained.It was concluded that the unacceptable biorad quality control results were isolated to the suboptimal calibrations generated from one set of vitros calibrator kit 32.Continual tracking and trending of complaints has not identified any signals that would point to potential systemic issues with vitros chemistry products k+ slides, lot 4102-1089-3607, lot 4102-1111-5623, or vitros chemistry products calibrator kit 32, lot 3222.

• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18249388
• Report Number: 0001319808-2023-00018
• Device Sequence Number: 17813866
• Product Code: JIX
• UDI-Device Identifier: 10758750032105
• UDI-Public: 10758750032105
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 12/01/2023

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: 08/08/2024
• Device Catalogue Number: 6844508
• Device Lot Number: 3222
• 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: 11/14/2023
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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