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

Catalog Number 8298671

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that both lower and higher than expected vitros phenytoin (phyt) results were obtained from non-vitros biorad quality control (qc) fluids and a higher than expected vitros phyt result was obtained from a vitros therapeutic drug monitoring performance verifier (tdm pv) using vitros chemistry products phenytoin (phyt) slides on a vitros 5600 integrated system.The investigation could not determine a definitive root cause for this event.The customer performed maintenance activities that included cleaning the reflectometer lens and changing the immuno wash fluid reservoir.The quality control results since the customer performed maintenance on the vitros 5600 integrated system indicate that vitros phyt lot 2618-0169-5504 is performing as intended.Based on historical quality control results a vitros phyt lot 2618-0169-5504 performance issue is not a likely contributor to the event.Furthermore, continual tracking and trending of complaints has not identified any signals that would suggest there is a potential systemic issue with vitros phyt reagent lot 2618-0169-5504.Additionally, an instrument issue did not likely contribute to the event as within run precision testing using both vitros phyt and vitros carbamazepine (crbm) reagent yielded results that were within acceptable guidelines.

Event Description

A customer reported imprecise vitros phyt results obtained from non-vitros biorad quality control (qc) fluids and a vitros therapeutic drug monitoring performance verifier (tdm pv) using vitros chemistry products phenytoin (phyt) slides on a vitros 5600 integrated system.Biorad lot 40960: level 1 vitros phyt result of 66.04 umol/l vs an expected result of 19.73 umol/l, level 3 vitros phyt results of 59.42 and 101.58 umol/l vs an expected result of 83.13 umol/l.Vitros tdm performance verifier ii: lot a6279 vitros phyt result of 84.68 umol/l vs an expected result of 68.2 umol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.No patient samples were questioned during the timeframe of this event.However, it cannot be concluded that patient sample results would not be affected if the event were to recur undetected.There has been no allegation of any patient harm as a result of the event.This report is number 2 of 4 mdr¿s for this event.Four (4) 3500a forms are being submitted for this event as 4 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint number (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: 8564239
• MDR Text Key: 195710529
• Report Number: 1319809-2019-00034
• Device Sequence Number: 1
• Product Code: DIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2019
• Device Catalogue Number: 8298671
• Device Lot Number: 2618-0169-5504
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2018
• 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