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

Catalog Number 8298671

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher and lower than expected phenytoin (phyt) results were obtained from multiple samples from a single patient using vitros chemistry products phyt slides lot 2620-0172-3406 on a vitros 5600 integrated system.The assignable cause of the event is twofold: 1.The variation in results within a sample could be due to an unknown sample interferent.2.User error where the customer diluted samples with results within the vitros phyt measuring range.An interferent within the patient samples could not be entirely confirmed nor ruled out as a contributor of the event as it is unknown if the patient had been taking any other medications besides dilantin at the time of the event.The customer diluted samples that initially produced results within the measuring range for vitros phyt and reported these results.Per the vitros phyt instructions for use and a medical consult, samples that produce initial results within the measuring range should not be diluted as to avoid any variations introduced by unnecessary sample dilution.Based on historical quality control results, a vitros phyt lot 2620-0172-3406 performance issue is not a likely contributor to the event.Furthermore, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros phyt reagent lot 2620 0172 3406.Within run precision testing performed by the customer on the vitros 5600 integrated system were within acceptable guidelines indicating that the vitros phyt slides and the instrument did not malfunction.Additionally, pre analytical sample processing could not be ruled out as a contributing factor as the customer was not following the sample collection device manufacturer¿s recommended centrifugation protocol.Improper pre analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.

Event Description

A customer obtained higher and lower than expected phenytoin (phyt) results from multiple samples from a single patient using vitros chemistry products phyt slides lot 2620-0172-3406 on a vitros 5600 integrated system.Patient 1 sample 2 vitros phyt results of 25.4 and 30.4 ug/ml versus a reported result of 45.9 ug/ml.Patient 1 sample 4 vitros phyt results of 21.0, >40, 39.9 and 42.1 ug/ml versus a reported result of 27.9 ug/ml.Patient 1 sample 6 vitros phyt result of 26.9 ug/ml versus a reported result of 34.1 ug/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.A result from each sample was reported outside of the laboratory.The physician questioned several of the results and had expected them to be gradually getting lower as the last known dose of dilantin had been administered to the patient prior to the event.It is unknown if the stoppage of treatment with dilantin was continued due to the higher than expected vitros phyt results.Ortho has not been made aware of any allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 9744985
• MDR Text Key: 223666984
• Report Number: 1319809-2020-00029
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: 8298671
• Device Lot Number: 2620-0172-3406
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2019
• 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