MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS K+ SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number	8157596
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a higher than expected potassium (k+) result was obtained from a quality control fluid using vitros chemistry products k+ slides lot 4102-1101-0944 on a vitros xt7600 integrated system.The assignable cause of the event is unknown.Historical quality control results were unacceptable for level 1 and level 3, indicating that an issue with vitros k+ reagent lot 4102-1101-0944 cannot be ruled out as a potential contributor to the event.However, continual tracking and trending does not indicate a systemic issue with vitros k+ reagent lot 4102-1101-0944.Diagnostic vitros sodium (na+) and alkaline phosphatase (alkp) precision testing was requested to assess the performance of the vitros xt7600 integrated system but was not processed by the customer.Therefore, an issue with the vitros xt7600 integrated system cannot be fully ruled out as a contributor to the event.The customer is not calibrating with each new lot of electrolyte reference fluid (erf) per the vitros k+ instructions for use and the operating instructions for the vitros xt7600 system.Improper erf protocol cannot be ruled out as a contributor to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected potassium (k+) result was obtained from a quality control fluid using vitros chemistry products k+ slides lot 4102-1101-0944 on a vitros xt7600 integrated system.Non-vitros mas omni-core lot 25111a result of >14.0 mmol/l versus the expected result of 2.67 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+ result was obtained from a non-patient fluid and was not reported from the laboratory.There was no allegation 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 603765.

• Brand Name: VITROS CHEMISTRY PRODUCTS K+ SLIDES
• 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.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18042298
• Report Number: 0001319809-2023-00126
• Device Sequence Number: 7465347
• Product Code: CEM
• UDI-Device Identifier: 10758750010233
• UDI-Public: 10758750010233
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (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): 10/31/2023

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: 10/01/2024
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1101-0944
• 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: 10/10/2023
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2023
• 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