MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 4600 CHEMISTRY SYSTEM; CHEMISTRY ANALYZER

Catalog Number	6802445
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros potassium (k+) results were obtained from a single level of non-vitros biorad lyphochek assayed chemistry controls, lot 89730, using vitros k+ slide lot 4102-1007-5442 on a vitros 4600 chemistry system.The assignable cause of the event was an instrument performance issue.An ortho laboratory specialist (ls) went on site and found the pm incubator and the pm incubator evaporation caps, versa tip supply and tip locator were very dirty.In addition, the erf metering tubing was obstructed.The ortho ls performed the as needed maintenance procedures of cleaning the pm incubator, pm evaporation caps, the electrometer voltage terminal, tip locator, primary metering proboscis/piston assembly and purging the erf metering tubing.The ortho ls then calibrated vitros k+ slide lot 4102-1007-5442.Acceptable vitros k+ slide lot 4102-1007-5442 results were obtained after performing the as-needed maintenance and calibration.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros potassium (k+) results were obtained from a single level of non-vitros biorad lyphochek assayed chemistry controls, lot 89730, using vitros k+ slide lot 4102-1007-5442 on a vitros 4600 chemistry system.Biorad level 3 k+ results of 4.99, 4.94, 4.74, 4.77, 476 and 4.69 mmol/l vs.The expected result of 5.83 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 affected quality control samples were non-patient samples.There were no 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 604391.

• Brand Name: VITROS 4600 CHEMISTRY SYSTEM
• Common Device Name: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18376181
• Report Number: 0001319809-2023-00191
• Device Sequence Number: 7579618
• Product Code: JJE
• UDI-Device Identifier: 10758750012343
• UDI-Public: 10758750012343
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 12/21/2023

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 Catalogue Number: 6802445
• 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: 11/30/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2013
• 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