MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 5600 INTEGRATED SYSTEM-REFURBISHED; CHEMISTRY ANALYZER

Catalog Number	6802915
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected results were obtained from non-vitros (biorad) qc fluids when processed using vitros tsh lot 7070, vitros b-hcg ii lot 3720 and vitros psa lot 4330 on a refurbished vitros 5600 integrated system.The most likely cause of the event is an instrument related issue.A diagnostic precision test following the lower than expected results from biorad qc testing indicating unacceptable instrument performance.The customer cleaned the microwell incubator and replaced the microimmunoassay metering proboscis as per recommendations from the ortho tsc.A diagnostic precision test following customer cleaning and maintenance actions on the instrument indicated acceptable instrument performance and vitros tsh, vitros b-hcg ii and vitros psa results from biorad qc testing were acceptable.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected results were obtained from non-vitros (biorad) qc fluids when processed using vitros tsh lot 7070, vitros b-hcg ii lot 3720 and vitros psa lot 4330 on a refurbished vitros 5600 integrated system.Biorad lot 85311 level 1, vitros tsh result of 0.461 miu/l versus the baseline mean result of 0.660 miu/l biorad lot 85313 level 3, vitros tsh result of 15.949 miu/l versus the baseline mean result of 26.330 miu/l biorad lot 85313 level 3, vitros b-hcg ii result of 350.203 miu/ml versus the baseline mean result of 537.5 miu/ml biorad lot 85313 level 3, vitros psa result of 9.694 ng/ml versus the baseline mean result of 15.860 ng/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 lower than expected vitros tsh, vitros b-hcg ii and vitros psa results were generated when the customer was processing non-patient fluids.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).

• Brand Name: VITROS 5600 INTEGRATED SYSTEM-REFURBISHED
• 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: 17607681
• Report Number: 0001319681-2023-00043
• Device Sequence Number: 6161923
• Product Code: JJE
• UDI-Device Identifier: 10758750007110
• UDI-Public: 10758750007110
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 08/23/2023

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: 6802915
• 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: 07/31/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2018
• 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