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	04/19/2024
Type of Reportable Event	Malfunction
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 a single level of non-vitros biorad control lot 853620 using vitros dgxn slide lot 1933-0269-9252, tested on a vitros 5600 integrated system.Biorad level 3 dgxn result of 1.47 ng/ml vs.An expected result of 3.00 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 affected quality control sample was a non-patient sample.The customer made no indication that patient sample results were affected.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).
Additional Manufacturer Narrative
The investigation determined that a lower than expected vitros digoxin (dgxn) result was obtained from a single level of non-vitros biorad control, lot 853620 using vitros dgxn slide lot 1933-0269-9252, tested on a vitros 5600 integrated system.The most likely assignable cause of the event is unknown.A review of non-vitros biorad quality control results obtained using vitros dgxn slide lot 1933-0269-9252 indicated there was within-lab imprecision within the timeframe of the event.Therefore, a performance issue with vitros dgxn slide lot 1933-0269-9252 cannot be ruled out as contributing to the event.However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros dgxn slide lot 1933-0269-9252.The customer made no indication the vitros 5600 system was not performing as intended, however, since no diagnostic within-run precision testing performed to assess the performance of the instrument an analyzer related performance issue cannot be completely ruled out as contributing to the event.No information was provide concerning the customer's sample handling protocol for the biorad quality control fluids, therefore, improper sample handling protocol cannot be ruled out as contributing to the event.

• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 19304800
• Report Number: 1319809-2024-00047
• Device Sequence Number: 12595891
• Product Code: LFM
• UDI-Device Identifier: 10758750004782
• UDI-Public: 10758750004782
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/10/2024

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 Expiration Date: 06/15/2024
• Device Catalogue Number: 8343386
• Device Lot Number: 1933-0269-9252
• 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: 04/23/2024
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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