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

Catalog Number 8298671

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/28/2021

Event Type  malfunction  

Event Description

A customer obtained higher than expected vitros phenytoin (phyt) results from vitros therapeutic drug monitoring performance verifiers (tdm pv) processed using vitros chemistry products phyt slides on two vitros 4600 chemistry systems.Analyzer 46001169: tdmpvi lot r7687 results of 12.1, 10.3, 11.1, 10.5, 10.5, 10.9, 11.0, 11.2 and 11.7 ug/ml vs the expected result of 8.3 ug/ml.Tdm pvii lot t7688 results of 18.0, 17.6, 16.9, 17.3, 17.5, 18.0, 25.1, 19.4, 19.1, 18.2, 17.8, 17.1, 17.7, 17.4, 16.9, 16.8, 16.8, 17.3, 22.1, 23.2, 27.1, 23.4, 22.1, 17.9, 28.6, 25.3, 19.2, 19.9, 20.2, 17.0, 17.3 and 17.4 ug/ml vs the expected result of 14.0 ug/ml.Analyzer 46000903: tdm pvii lot t7688 result of 17.3 ug/ml vs the expected result of 14.0 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 customer, through the distributor field engineer, indicated that patient results were reported outside of the laboratory while running vitros phyt during the timeframe of the event.However, the results were not questioned by a physician and no repeats were requested for any of the samples.It cannot be confirmed that patient results would not be affected if the issue were to recur undetected.There is no allegation of patient harm as a result of this event.This report is number 40 of 42 mdr¿s for this event.Forty-two (42) 3500a forms are being submitted for this event as 42 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint (b)(4).

Manufacturer Narrative

The investigation determined that higher than expected vitros phenytoin (phyt) results were obtained from vitros therapeutic drug monitoring performance verifiers (tdm pv) processed using vitros chemistry products phyt slides lot 2621-0175-3482 on two vitros 4600 chemistry systems.The assignable cause of the event is unable to be determined with the information provided.Historical quality control results show inaccuracy for vitros tdm pvii, and imprecision for both levels of vitros tdm pv fluids.This indicates that vitros phyt lot 2621-0175-3482 is not performing as expected in combination with the vitros 4600 chemistry systems.The customer did not process any of the requested diagnostic precision tests.Therefore, it is unknown if a regent issue or an analyzer issue contributed to the higher than expected results.Continual tracking and trending does not indicate a systemic issue with vitros phyt lot 2621-0175-3482.The fluid and reagent handling protocol cannot be ruled out as a contributor to the event.The customer processed multiple results using onboard expired reagents.Additionally, it is unknown if the fluid or reagent warm up times used were acceptable per the vitros phyt instructions for use.(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
• MDR Report Key: 11567826
• MDR Text Key: 280508204
• Report Number: 1319809-2021-00066
• Device Sequence Number: 1
• Product Code: DIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2021
• Device Catalogue Number: 8298671
• Device Lot Number: 2621-0175-3482
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1