MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 3600 IMMUNODIAGNOSTIC SYSTEM; CHEMISTRY ANANLYZER

Catalog Number	6802783
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that higher than expected biorad and vitros qc results were obtained following the calibration of vitros tsh reagent lot 7200 on a vitros 3600 immunodiagnostic system.The assignable cause was user error, the operator manually entered calibration data rather than performing a wet calibration using calibrator fluids as recommended in the vitros user manual.The quality control results were acceptable after the customer recalibrated vitros tsh lot 7200 with fresh poured calibrator fluids.There is no indication that the vitros 3600 immunodiagnostic system or the vitros tsh reagent malfunctioned.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected biorad and vitros qc results were obtained following the calibration of vitros tsh reagent lot 7200 on a vitros 3600 immunodiagnostic system.Biorad lot 40410, level 3 reuslt of 42.50 versus the expected result of 32.6 miu/ml vitros free thyroid control lot 761, level 2 result of 1.712 versus the expected result of 1.31 miu/ml vitros free thyroid control lot 761, level 3 result of 27.68 versus the expected result of 20.2 miu/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros tsh results were obtained from non-patient fluids.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 3600 IMMUNODIAGNOSTIC SYSTEM
• Common Device Name: CHEMISTRY ANANLYZER
• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18896277
• Report Number: 1319681-2024-00020
• Device Sequence Number: 7738370
• Product Code: JJE
• UDI-Device Identifier: 10758750002979
• UDI-Public: 10758750002979
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2024

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: 6802783
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown