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 Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, higher than expected phenytoin (phyt) result was obtained from a single patient sample using vitros chemistry products phyt slides lot 2619-0171-0558 on a vitros 5600 integrated system.The most likely assignable cause is a sample related issue, likely due to improper pre-analytical sample handling protocol.The customer was not able to provide details on the sample appearance at the time of processing, however the sample showed elevated hemolysis and turbidity that increased after the initial run of the sample.Per the vitros phyt instructions for use, hemolyzed samples should not be used.In addition, the customer was not following the sample collection device manufacturer¿s recommendation for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Based on historical quality control results, a vitros phyt lot 2619-0171-0558 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 2619-0171-0558.Additionally, vitros phyt within run precision testing was performed by the customer on the vitros 5600 integrated system.The testing yielded results that were within acceptable guidelines, further indicating a reagent issue is unlikely.The customer did not process a vitros crbm marker precision test as requested to confirm the performance of the analyzer, however, an issue with the vitros 5600 integrated system is unlikely based on historical and current performance.

Event Description

A customer reported a non-reproducible, higher than expected vitros phenytoin (phyt) result from a single patient sample processed using vitros chemistry products phyt slides in combination with a vitros 5600 integrated system.Patient sample result of 21.90 ug/ml vs.An expected result of 17.12 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros phyt patient result was reported outside of the laboratory, however, a corrected report was later issued.No treatment was initiated, altered or stopped based upon the initial reported result and ortho has not been made aware of any allegation of patient harm as a result of this event.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: 9307202
• MDR Text Key: 214621332
• Report Number: 1319809-2019-00111
• 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: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2019
• Device Catalogue Number: 8298671
• Device Lot Number: 2619-0171-0558
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2019
• 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