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

Catalog Number 8298671

Device Problem Low Test Results (2458)

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

Event Date 08/13/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower 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 vitros xt7600 integrated system, j76000432.The assignable cause of the event is unknown.Quality control results for both lots of vitros phyt showed inaccuracy and imprecision for the two levels at higher concentrations.Although acceptable performance was obtained using an alternate non-vitros biorad quality control, this control was not run consistently and therefore it could not be confirmed that the issue was isolated to the mas control.Acceptable results were obtained at various times on all levels with the mas control with no action to the analyzer, therefore a reagent issue with either of the two lots is not a likely contributor to the event.Additionally, diagnostic precision testing performed using vitros alkp and vitros phyt lot 2625-0185-2783 were within ortho acceptable guidelines, confirming that the vitros xt7600 system and the vitros phyt reagent were not likely contributors to the event.The customer indicated that they are following the instructions for use for calibration preparation and quality control fluid handling, therefore a fluid handling issue cannot be confirmed as a contributor to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phyt slide lots 2625-0185-2295 or 2625-0185-2783.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower 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 vitros xt7600 integrated system, j76000432.Phyt lot 2625-0185-2295: vitros phyt lot 2625-0185-2295 mas fluid results of 22.40, 21.19 and 20.71 ug/ml versus the mas peer mean of 28.7 ug/ml phyt lot 2625-0185-2783: vitros phyt lot 2625-0185-2783 mas fluid results of 18.09, 17.81, 18.94, 19.68, 20.75, and 22.36 ug/ml versus the mas peer mean of 28.7 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 than expected results were obtained from non-patient quality control fluids.There was no allegation of patient harm as a result of this event.This report is number seven of nine mdr¿s for this event.Nine 3500a forms are being submitted for this event as nine devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4), and reportability assessment (b)(4).

• 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: 17748251
• MDR Text Key: 323698136
• Report Number: 0001319809-2023-00101
• Device Sequence Number: 1
• Product Code: DIP
• UDI-Device Identifier: 10758750004690
• UDI-Public: 10758750004690
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2023
• Device Catalogue Number: 8298671
• Device Lot Number: 2625-0185-2783
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1