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

Catalog Number 8298671

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation was unable to determine a definitive assignable cause for the event.There was no evidence that a vitros phyt reagent issue or a vitros 5600 system issue contributed to the lower than expected vitros phyt result.Vitros alt, phyt and crbm within-run precision tests were used to assess instrument performance and were within acceptance criteria, indicating the vitros 5600 instrument was performing as intended.Based on historical quality control data, a vitros phyt lot 2614-0161-4738 reagent issue can be ruled out as a contributing factor.Pre analytical sample processing could not be ruled out as a contributing factor.It is unknown if the customer is processing the samples following the sample collection device manufacturer¿s recommendations.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.

Event Description

A customer obtained a lower than expected vitros phyt result from a single patient sample using vitros phyt slides on a vitros 5600 integrated system.Patient results = 14.6 ug/ml versus an expected result of 33.36 ug/ml.Biased results of the direction and magnitude observed could lead to inappropriate physician action.The lower than expected vitros phyt patient result was reported outside of the laboratory and a corrected report was issued.There was no allegation of actual patient harm.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS 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: 6274510
• MDR Text Key: 66369636
• Report Number: 1319809-2017-00014
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2017
• Device Catalogue Number: 8298671
• Device Lot Number: 2614-0161-4738
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2016
• 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