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

Catalog Number 8298671

Device Problem Low Test Results (2458)

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

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a non-reproducible, lower than expected phenytoin (phyt) result was obtained from a single patient sample using vitros chemistry products phyt slides lot 2619-0171-2892 on a vitros xt7600 integrated system.A definitive assignable cause could not be determined.However, based on the investigation the most likely cause is a sample related issue.The customer processed the patient sample at a higher rcf than that recommended by the device manufacturer.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this cannot be confirmed.Based on historical quality control results, a vitros phyt lot 2619-0171-2892 performance issue is not a likely contributor to the event.Additionally, 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 2619-0171-2892.However, because the site ran out of vitros phyt reagent lot 2619-0171-2892 before the within run precision testing could be run using it, a reagent lot issue could not be entirely ruled out as contributing to the event.Vitros phyt within run precision testing using an alternate lot of reagent 2620-0172-5817 and marker precision testing using vitros alkp slides were performed by the customer on the vitros xt7600 integrated system.The testing yielded results that were within acceptable guidelines suggesting an instrument issue did not likely contribute to the event.The customer did not process a vitros crbm marker precision, therefore an issue with the immunowash fluid module cannot be ruled out as a potential cause of the event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report a non-reproducible, lower than expected phenytoin (phyt) result obtained from a single patient sample using vitros chemistry products phyt slides on a vitros xt7600 integrated system.Patient sample result of 6.50 ug/ml vs.An expected result of 10.20 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 non-reproducible, lower than expected vitros phyt result was reported from the laboratory.However, no treatment was initiated, altered or stopped based upon the reported result.A corrected report was later issued, 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 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: 9768672
• MDR Text Key: 213916233
• Report Number: 1319809-2020-00030
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2020
• Device Catalogue Number: 8298671
• Device Lot Number: 2619-0171-2892
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2019
• 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