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

Catalog Number 8298671

Device Problems Incorrect Or Inadequate Test Results (2456); High Test Results (2457); Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that multiple higher and lower than expected vitros phyt results were obtained from two different quality control samples processed on a vitros 350 chemistry system.The investigation was unable to determine a definitive assignable cause.Service actions were performed on the instrument, however, pre-service within-run precision testing used to verify instrument performance was inconclusive.Therefore, an instrument issue cannot be ruled out as a contributing factor.The phyt qc performance was acceptable on both levels of qc prior to the event.This would suggest a vitros phyt slide lot issue is not a likely contributing factor to this event but could not be entirely ruled out.A sub-optimal calibration event occurred prior to the higher than expected phyt results.The cause of the sub-optimal calibration is not known, but it cannot be ruled out as a contributing factor to the higher than expected results.A definitive root cause for the event could not be determined.

Event Description

The customer observed multiple higher and lower than expected vitros phenytoin (phyt) results predicted from two different vitros performance verifier quality control fluids processed on a vitros 350 chemistry system.Phyt result for pvi lot l5005 of 9.57, 10.08 ug/ml verses an expected baseline mean of 12.9 ug/ml.Phyt result for pvii lot m5007 of 15.17, 13.54, 15.21, 13.27, 13.05, 26.08, 58.5, 53.9, 58.2, 59.0, 58.5, 59.8, 56.9, 56.4, 59.9, 54.1, 58.8, 58.9, and 54.0 ug/ml verses an expected baseline mean of 21.4 ug/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 19 of 21 mdr¿s for this event.Twenty one (21) 3500a forms are being submitted for this event as 21 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: 6527768
• MDR Text Key: 74151250
• Report Number: 1319809-2017-00066
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2017
• Device Catalogue Number: 8298671
• Device Lot Number: 2614-0161-7201
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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