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

Catalog Number 8298671

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

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

Event Date 07/13/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher and lower than expected vitros phenytoin (phyt) results were obtained from samples from three different patients using one lot of vitros phyt slides in combination with a vitros 5600 integrated system.A reagent issue cannot be ruled out as a potential cause.Historical quality controls (qc) for both analyzers shows acceptable accuracy and precision for vitros phyt lot 2617-0170-8772, however a precision run on j56001435 just passed within specifications, and a precision run on j56001428 failed with this lot.A precision run using new vitros phyt lot 2619-0171-0597 was passing on both analyzers, with sd¿s much lower than the previous lot.This indicates a potential issue with the in-use cartridges of vitros phyt lot 2617-0170-8772 at the time the event occurred, although this cannot be confirmed.Although performance was improved with vitros phyt lot 2619-0171-0597, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phyt lot 2617-0170-8772.Additionally, the customer is not following the tube manufacturers recommendation¿s for sample handling.The manufacturer recommends centrifuging samples at

Event Description

A customer obtained higher and lower than expected vitros phenytoin (phyt) results from samples from three different patients using one lot of vitros phyt slides in combination with a vitros 5600 integrated system.Patient 1 result of 30.46 ug/ml versus expected result of 3.20 ug/ml.Patient 2 results of 13.44, 13.24 and 13.57 ug/ml versus expected result of 21.14 ug/ml.Patient 3 results of 16.7 ug/ml versus expected result of 22.59 ug/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.One higher than expected vitros phyt result was reported from the laboratory, but a corrected report was later issued.There was no treatment altered for any of the patients and ortho has not been made aware of any allegation of actual patient harm as a result of this event.This report is number five of five mdr¿s for this event.Five 3500a forms are being submitted for this event as a total of five devices were involved.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 DIGANOSTIC
• 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: 8910128
• MDR Text Key: 214589921
• Report Number: 1319809-2019-00061
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2019
• Device Catalogue Number: 8298671
• Device Lot Number: 2617-0170-8772
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2019
• 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