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 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected phyt results were obtained from four different proficiency samples using a vitros 350 chemistry system.The assignable cause of this event is unknown, however, improper pre-analytical sample handling cannot be ruled out as contributing to the event.Additionally, an unknown instrument related issue cannot be completely ruled out as contributing to the event.A vitros crbm within-run precision test, used to assess the performance of the vitros 350 system, was not processed, therefore the performance of the vitros 350 system was not assessed.Based on acceptable historical quality control results, there was no indication vitros phyt slide lot 2614-0159-2934 contributed to the event.

Event Description

A customer obtained lower than expected results from four proficiency samples using vitros phenytoin (phyt) micro slides on a vitros 350 chemistry system.Proficiency sample ch-01 result of 20.2 ug/ml vs.The peer target of 31.06 ug/ml; proficiency sample ch-02 result of 5.6 ug/ml vs.The peer target of 7.98 ug/ml; proficiency sample ch-04 result of 4.2 ug/ml vs.The peer target of 6.70 ug/ml; proficiency sample ch-05 result of 7.6 ug/ml vs.The peer target of 9.63 ug/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if occurred undetected.There was no allegation of patient harm as a result of this event.However, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected.This report is number 2 of 4 mdr's for this event.Four (4) 3500a forms are being submitted for this event as 4 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: 5906418
• MDR Text Key: 54151015
• Report Number: 1319809-2016-00081
• 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: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: 8298671
• Device Lot Number: 2614-0159-2934
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• 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