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

Model Number	6802445
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2022, a customer reported that when their vitros 4600 chemistry system was running a sample in position 1, it would then go to position 5 for reflex dilution.In the observed case, no tube was in position 5.The investigation determined that the assignable cause of the event was user error.The investigation established that the saha_reflex_pos setting had been changed on 01 december 2022 by an unknown person.The saha_reflex_pos setting was reset and optimized by an ortho field engineer (fe) and once corrected, acceptable instrument performance was demonstrated to the customer.The customer was satisfied with the ortho fe actions performed and will monitor the instrument performance over the coming days and inform ortho of any further incidents if observed.
Event or Problem Description
On (b)(6) 2022, a customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report that their vitros 4600 chemistry system was running a sample in position 1, it would then go to position 5 for reflex dilution.In the observed case, no tube was in position 5.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The customer identified the discrepancy, and no erroneous results were knowingly reported from the laboratory.The customer and ortho have not been made aware of any allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4).

• 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: 16097693
• Report Number: 0001319681-2023-00001
• Device Sequence Number: 15157718
• Product Code: JJE
• UDI-Device Identifier: 10758750012343
• UDI-Public: 10758750012343
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 01/04/2023

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: 6802445
• 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: 12/09/2022
• Initial Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2013
• 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