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

Model Number	6802153
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros potassium (k+) results were obtained from a single level of vitros performance verifier (pv) i, lot m9814, tested on a vitros 350 chemistry system.The assignable cause of the event is user error.The customer used the incorrect calibrator supplemental assigned values (sav) when performing the initial calibration.The customer selected calibrator kit lot 0272 in the calibration software, however, used calibrator kit lot 3222 when performing the calibration.Acceptable vitros k+ performance was obtained when the correct calibrator lot (lot 3222) was selected in the calibration software.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros potassium (k+) result was obtained from a single level of vitros performance verifier (pv) i, lot m9814, tested on a vitros 350 chemistry system.Vitros pv i lot m9814 result of 4.1 mmol/l, vs.The expected result of 2.92 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 vitros pv i fluid was a non-patient sample, and the result was not reported outside of 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 (b)(4).

• Brand Name: VITROS 350 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: 17083386
• Report Number: 0001319681-2023-00033
• Device Sequence Number: 6273460
• Product Code: JJE
• UDI-Device Identifier: 10758750002054
• UDI-Public: 10758750002054
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): 06/07/2023

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 Model Number: 6802153
• 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: 05/12/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2013
• 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