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

Catalog Number 8298671

Device Problems High Test Results (2457); Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower and higher than expected vitros phenytoin (phyt) results were obtained from a single level non-vitros mas quality controls, lot ocr25113, using two lots of vitros phyt tested on a vitros xt7600 integrated system.Phyt lot 2626-0186-5242 mas level 3 lot 25113 fluid results of 16.09, 19.35, 18.18, 20.54, 35.40, 19.78, 20.83, 18.75, 18.43, 15.22, and 19.06 ug/ml versus the mas peer mean of 28.6 ug/ml phyt lot 2625-0185-2782 mas level 3 lot 25113 fluid results of 35.03 and 35.25 ug/ml versus the mas peer mean of 28.6 ug/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 and higher than expected results were obtained from a non-patient quality control fluid.There was no allegation of patient harm as a result of this event.This report is number two of thirteen mdr¿s for this event.Thirteen 3500a forms are being submitted for this event as thirteen devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).

Manufacturer Narrative

The investigation determined that lower and higher than expected vitros phenytoin (phyt) results were obtained from a single level non-vitros mas quality controls, lot ocr25113, using two lots of vitros phyt tested on a vitros xt7600 integrated system.The definitive assignable cause of the event cannot be determined with the information provided.The most likely assignable cause was an unknown issue with the non-vitros thermofisher mas ocr25113 control.Acceptable vitros phyt lot 2626-0186-5242 and 2625-0185-2782 performance was obtained consistently from the non-vitros thermofisher mas level 1 lot ocr25111 fluid.Additionally, the customer processed vitros therapeutic drug monitoring performance verifier fluids using vitros phyt lot 2625-0185-2782 and obtained acceptable results, further supporting that the reagent in combination with the xt7600 integrated system is not a likely contributor to the event, and that the issue is isolated to the non-vitros thermofisher mas level 3 lot ocr25113 fluid.However, as the customer did not process a within-run precision to verify the performance of the vitros xt7600 system, has not consistently processed the tdm pv fluids on either lot, and per e-connectivity has not been processing patient samples routinely, it is unknown if patient results would be affected if the event were to recur undetected.Vitros phyt lot 2626-0186-5242 was depleted, and it was not possible to process the tdm pv fluids or additional patient samples using this lot.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phyt slide lots 2626-0186-5242 and 2625-0185-2782.A review of vitros phyt complaints indicates a potential issue with mas ocr lot 2406 and mas ocr lot 2511 level 3 controls as there were 5 additional complaints regarding lower and higher than expected results using these lots of control fluids with vitros phyt.

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT SLIDES
• Type of Device: 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: 18187245
• MDR Text Key: 329225093
• Report Number: 0001319809-2023-00161
• Device Sequence Number: 1
• Product Code: DIP
• UDI-Device Identifier: 10758750004690
• UDI-Public: 10758750004690
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Catalogue Number: 8298671
• Device Lot Number: 2626-0186-5242
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1