MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 350 CHEMISTRY SYSTEM; IN-VITRO DIAGNOSTICS

Catalog Number	6802153
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected potassium results were obtained from a non-vitros mas quality control fluid using vitros chemistry products potassium (k+) slides lot 4102-1106-2795 and lot 4102-1099-0284 on a vitros 350 chemistry system.The assignable cause of the event is an instrument issue.The customer was experiencing ongoing issues since approximately (b)(6) 2023 with condition code ¿6bg pf-prediction * electrometer results outside limit¿ and humidity issues.The customer had service actions performed on (b)(6), (b)(6), (b)(6) and (b)(6) 2023 leading up to this event when the final service actions took place on (b)(6) 2023.Prior service actions included replacing the electrometer and cable, wear pads, belt, electrolyte reference fluid pump and dispense blade.On (b)(6) 2023 the ortho field engineer (fe) found that the connectors on the humidity plate were swapped for the salt pads and the desiccants.The ortho fe reversed the connectors so that they were correct, and changed the salt pads and desiccant packs, then verified that humidity came into and stayed in the acceptable range.The customer has reported no further issues since the service actions on (b)(6) 2023.Continual tracking and trending does not indicate a systemic issue with vitros chemistry products k+ slides lot 4102-1106-2795 or lot 4102-1099-0284.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected potassium results were obtained from a non-vitros mas quality control fluid using vitros chemistry products potassium (k+) slides lot 4102-1106-2795 and lot 4102-1099-0284 on a vitros 350 chemistry system.Vitros k+ lot 4102-1106-2795 vitros k+ mas level 3 results of 4.14 and 4.39 mmol/l vs the expected result of 6.22 mmol/l vitros k+ lot 4102-1099-0284 vitros k+ mas level 3 results of 4.11 mmol/l vs the expected result of 6.22 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 vitros k+ results were obtained from a non-patient fluid.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 (b)(4).

• Brand Name: VITROS 350 CHEMISTRY SYSTEM
• 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.; 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: 17699170
• Report Number: 0001319681-2023-00048
• Device Sequence Number: 12442255
• Product Code: JJE
• UDI-Device Identifier: 10758750002054
• UDI-Public: 10758750002054
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/06/2023

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: 6802153
• 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: 08/12/2023
• Initial Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2017
• 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