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 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

The assignable cause of the event cannot be determined.A fluid handling issue with the immuno wash fluid (iwf) is suspected to be a contributing factor, but cannot be confirmed.The acceptable qc performance suggests a vitros phyt slide lot issue is not a likely contributing factor to this event.Acceptable within run marker precision testing indicates that the instrument can be ruled out as a contributing factor.

Event Description

A customer obtained lower than expected vitros phyt results from non-vitros quality control fluids on a vitros 5600 integrated system.Phyt result for qc fluid lot 40921 of <3 ug/ml verses an expected baseline mean of 5.15 ug/ml.Phyt result for qc fluid lot 40903 of 5.7 ug/ml verses an expected baseline mean of 21.6 ug/ml.Biased results of the direction and magnitude observed could lead to inappropriate physician action.There were no patient results reported outside of the laboratory.There was no allegation of patient harm as a result of this event.However, the investigation cannot conclude that patient samples were not affected or would not be affected if the event were to recur undetected.This report is number one of two mdr's for this event.Two 3500a forms are being submitted for this event as two devices were involved.(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: 6570929
• MDR Text Key: 75442877
• Report Number: 1319809-2017-00070
• 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: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Catalogue Number: 8298671
• Device Lot Number: 2614-0162-8103
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1