MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS DGXN SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number	8343386
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a lower than expected vitros digoxin (dgxn) result was obtained from an institute for quality management in healthcare (iqmh) proficiency sample when processed using vitros dgxn microslides on a vitros xt7600 integrated system.A definitive assignable cause was not determined.A review of historical vitros dgxn quality control indicates acceptable performance, indicating that an issue with the vitros dgxn slide lot 1930-0267-3516 was not a likely contributor to the event.The customer did not process any within run precision testing at the time the proficiency testing was performed, therefore a transient issue with the vitros xt7600 system cannot be confirmed or ruled out as a contributor to the event.However, an instrument issue is not a likely contributor to the event as the customer was able to obtain an acceptable result using an alternate lot of vitros dgxn with no actions performed on the analyzer.The customer gave no indication that there were any issues with the reconstitution of the proficiency samples, and an acceptable result was obtained when repeat testing was performed using the same sample on the customers current in-use lot of vitros dgxn, therefore an issue with the proficiency sample is not a likely contributor to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected vitros digoxin (dgxn) result was obtained from an institute for quality management in healthcare (iqmh) proficiency sample when processed using vitros dgxn microslides on a vitros xt7600 integrated system.Iqmh sample (b)(6) result of 1.9 versus mean 2.8 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 results were obtained from an iqmh proficiency fluid.Ortho was not made aware of any erroneous patients results obtained or reported from the laboratory.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS DGXN SLIDES
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18268902
• Report Number: 0001319809-2023-00178
• Device Sequence Number: 7914738
• Product Code: LFM
• UDI-Device Identifier: 10758750004782
• UDI-Public: 10758750004782
• 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): 12/05/2023

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 Expiration Date: 12/15/2023
• Device Catalogue Number: 8343386
• Device Lot Number: 1930-0267-3516
• 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: 11/10/2023
• Initial Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2023
• 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