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

Catalog Number 8298671

Device Problem Low Test Results (2458)

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

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros phenytoin (phyt) result was obtained from a (b)(6) proficiency sample when tested on a vitros 5600 integrated system.The assignable cause of this event is user error due to inappropriate interpretation of an instrument wash error flag generated by the vitros 5600 instrument.The customer did not follow the instructions listed in the actions to perform for the wash error (we) flag and the u90-382 condition code, in order to be able to indicate what the phyt concentration of the cap sample may be.The vitros 5600 integrated system did not generate a phyt result when the proficiency sample was initially run undiluted due to the occurrence of a ¿we¿ flag.The fluid matrix of the proficiency sample most likely contributed to the we flag, and the vitros 5600 instrument was unable to generate a result from that sample.The vitros 5600 instrument operated as intended when the wash error flag was generated, and no phyt result was able to be generated for the sample.The investigation found no evidence to suggest a malfunction of the vitros 5600 integrated system or vitros phyt lot 2617-0168-2514.

Event Description

A customer obtained a lower than expected vitros phenytoin (phyt) result from a cap (college of american pathologist) proficiency sample when tested on a vitros 5600 integrated system.Cap sample chm-13, vitros phyt result 3.0 ug/ml versus the vitros peer mean result 5.69 ug/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected vitros phyt result was obtained when the customer was processing a proficiency sample.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There was no 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: 8322692
• MDR Text Key: 138221540
• Report Number: 1319809-2019-00004
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2019
• Device Catalogue Number: 8298671
• Device Lot Number: 2617-0168-2514
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2012
• 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