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

Catalog Number 8298671

Device Problems High Test Results (2457); Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower and higher than expected results were obtained from quality control fluids using vitros phyt micro slides on a vitros 5600 integrated system.The most likely assignable cause of the vitros tdm pv iii d5002 results of 35.2, 39.6, >40.0, and >40.0 ug/ml was the calibration associated with the results, as these results were obtained to verify a calibration event.The investigation was unable to identify an assignable cause for the remaining lower than expected tdm pv results that were obtained from a previous calibration.However, there was no evidence that vitros phyt slide lot 2614-0162-7383 or the vitros 5600 system malfunctioned.Historical quality control results obtained using slide lot 2614-0162-7383 were acceptable prior to, and after the event, with no actions taken to mitigate the issue.Finally, a phyt within-run precision test was within acceptable guidelines, indicating vitros slide lot 2614-0162-7383 is performing as intended on the vitros 5600 system.A sample related issue related to the vitros tdm pv fluids in use at the time of the events cannot be ruled out as contributing to the event.The customer was asked if improper pre-analytical sample handling could be the cause of the issue, however, the customer could neither rule out nor confirm if improper sample handling occurred.

Event Description

A customer obtained lower and higher than expected results from quality control fluids using vitros phenytoin (phyt) microslides on a vitros 5600 integrated system.Vitros tdm pv i x4558 results of 5.11, 5.26, 5.41 ug/ml vs.The expected result of 7.60 ug/ml.Vitros tdm pv iii d5002 results of 9.61, 13.4 16.7, 35.2, 39.6, >40.0, and >40.0 ug/ml vs.The expected result of 28.70 ug/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if occurred undetected.These results were not reported from the laboratory and there was no allegation of patient harm as a result of this event.This report is number 3 of 10 mdr¿s for this event.Ten (10) 3500a forms are being submitted for this event as 10 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: 6475106
• MDR Text Key: 72783689
• Report Number: 1319809-2017-00030
• 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: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: 8298671
• Device Lot Number: 2614-0162-7383
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1