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

Model Number	1922814
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros b-hcg ii (bhcg) result was obtained from a single patient sample using vitros immunodiagnostics products bhcg reagent in combination with a vitros eci q immunodiagnostic system.Patient 1 result of 1542 miu/ml versus expected result of < 2.39 miu/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, higher than expected, vitros bhcg result was not reported from the laboratory and ortho has not been made aware of any 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).
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros b-hcg ii (bhcg) result was obtained from a single patient sample using vitros immunodiagnostics products bhcg reagent in combination with a vitros eci q immunodiagnostic system.The most likely assignable cause is instrument related.An ortho field engineer (fe) undertook maintenance actions including replacing the reagent metering probe, air injection tubing, signal reagent a probe and dispense tips, well wash aspirate filter, the deralin roller and cleared the signal reagent vent a blockage.Following the cleaning and maintenance actions performed by the ortho fe, vitros bhcg within run precision testing was performed and produced acceptable results and reagent calibrations and qc fluids were successfully processed by the customer.The customer accepted the instrument back into use as repairs have returned this instrument to expected operation.

• Brand Name: VITROS ECIQ IMMUNODIAGNOSTIC 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: 16484781
• Report Number: 0001319681-2023-00015
• Device Sequence Number: 17832340
• Product Code: KHO
• UDI-Device Identifier: 10758750000272
• UDI-Public: 10758750000272
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/03/2023

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: 1922814
• Device Catalogue Number: 1922814
• 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: 02/06/2023
• Initial Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2016
• 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