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 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

During the investigation of imprecise vitros phenytoin (phyt) results, lower than expected vitros phyt results were obtained from a vitros therapeutic drug monitoring performance verifier iii (tdm pviii) control fluid during two separate within run precision tests using vitros chemistry products phenytoin slides lot 2619-0171-1995 in combination with a vitros 5600 integrated system.The most likely assignable cause is an issue related to the vitros phyt reagent lot 2619-0171-1995.Two vitros phyt precision tests were run by the customer and failed using vitros phyt lot 2619-0171-1995.The customer processed another precision test using an alternate lot of vitros phyt reagent, with no other actions, which yielded passing results.The customer has reported no additional issues with imprecision since switching to the alternate lot of vitros phyt reagent.Although the vitros phyt reagent is the likely cause of the events, historical quality control data for vitros phyt lot 2619-0171-1995 indicated acceptable performance.Additionally, a complaint review did not identify any additional precision complaints on vitros phyt lot 2619-0171-1995.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phyt lot 2619-0171-1995.

Event Description

A customer reported imprecise vitros phyt results obtained from a vitros therapeutic drug monitoring performance verifier iii (tdm pviii) control fluid using vitros chemistry products phenytoin (phyt) slides on a vitros 5600 integrated system.Vitros tdm pv iii lot l7179 phyt results of 19.55 and 17.69 ug/ml versus the customer¿s vitros phyt baseline mean of 26.97 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 lower than expected results stemmed from quality control fluids, and patient results were not affected.However, it cannot be concluded that patient sample results would not be affected if the event were to recur undetected.There has been no allegation of patient harm as a result of the event.This report is number 2 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.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: 9344609
• MDR Text Key: 214622652
• Report Number: 1319809-2019-00113
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2020
• Device Catalogue Number: 8298671
• Device Lot Number: 2619-0171-1995
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2019
• 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