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

Catalog Number 8298671

Device Problem High Test Results (2457)

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

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros phenytoin (phyt) results were obtained from a vitros therapeutic drug monitoring performance verifier (tdm pv) quality control (qc) fluid using vitros chemistry products phyt slides lot 2621-0174-1701 on a vitros 5600 integrated system.The definitive cause of the event was most likely related to the vitros phyt lot 2621-0174-1701 slides in use at the time of the event.Within-run precision test results were outside of acceptance limits using this reagent lot on two different vitros 5600 systems.Acceptable within-run precision test results were obtained on both vitros 5600 systems using an alternate vitros phyt slide lot.An instrument related issue did not likely contribute to the event as two different vitros 5600 systems were affected, and acceptable vitros phyt performance was obtained using an alternate vitros phyt slide lot without any other actions taken that would affect performance.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phyt lot 2621-0174-1701.

Event Description

A customer obtained higher than expected vitros phenytoin (phyt) results from a vitros therapeutic drug monitoring performance verifier (tdm pv) quality control (qc) fluid using vitros chemistry products phyt slides on a vitros 5600 integrated system.Vitros tdm pv iii lot w7852 phyt results of 32.22, 31.34, 32.18, 32.92 and 32.00 ug/ml vs.The expected result of 26.1 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 higher than expected results were attained from a qc fluid.However, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.There have not been any allegations of patient harm as a result of this event.This report is number 1 of 5 mdr¿s for this event.Five (5) 3500a forms are being submitted for this event as 5 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT SLIDES
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10717600
• MDR Text Key: 249654810
• Report Number: 1319809-2020-00127
• Device Sequence Number: 1
• Product Code: DIP
• 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
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: 8298671
• Device Lot Number: 2621-0174-1701
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1