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

Catalog Number 8298671

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that multiple higher than expected vitros phyt results were obtained from a single vitros tdm pv iii fluid processed on a vitros 4600 chemistry system.The investigation was unable to determine a definitive assignable cause.The accuracy of vitros phyt slide lot 2614-0162-8097 was verified by acceptable historical phyt quality control results and the vitros 4600 system performance was verified by acceptable vitros phyt within run precision test results.Therefore there is no evidence that a reagent or analyzer issue contributed to the event.However, an unexpected reagent or analyzer issue could not be entirely ruled out as contributors to the higher than expected vitros phyt results obtained when testing vitros tdm pviii control.A pre-analytical fluid handling issue cannot be ruled out as contributing to the event.The higher than expected vitros phyt results were isolated to the vitros tdm pviii control.The calculated mean of the within run vitros phyt precision results are well centered within the vitros tdm pviii rom verifying the accuracy of vitros phyt lot 2614-0162-8097, therefore, a improper fluid handling of the affected control fluid on the date of the event cannot be ruled out.A definitive root cause for the event could not be determined.

Event Description

The customer observed multiple higher than expected vitros phenytoin (phyt) results obtained from a single vitros therapeutic drug monitoring performance verifier (tdm pv) fluid processed on a vitros 4600 chemistry system.Vitros tdm performance verifier iii: 37.18, 36.75, and 34.74 g/ml vs.The expected result of 28.9 g/ml.The customer made no allegations that patient sample results were affected.However, biased patient results of the direction and magnitude observed may lead to inappropriate physician action if occurred undetected.There was no allegation of patient harm.This report is number two of three 3500a forms filed for this event, as three devices were affected.(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: 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 6504809
• MDR Text Key: 74066165
• Report Number: 1319809-2017-00045
• 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: 04/19/2017

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: 06/15/2017
• Device Catalogue Number: 8298671
• Device Lot Number: 2614-0162-8097
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2016
• 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