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

Catalog Number 8298671

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that non-reproducible vitros phyt (phenytoin) results were obtained from two different samples collected from the same patient tested on two different vitros 5600 integrated systems.The investigation was unable to determine a definitive assignable cause for this event, however, a sample matrix issue related to the affected patient cannot be ruled out.The issue is isolated only to samples collected from the affected patient, as other patient samples run over this time frame did not demonstrate a similar issue.Quality control and precision test results from the time frame of the event demonstrated acceptable within-laboratory and within-run performance of the vitros phyt slide lot 2618-0169-6447.Ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros phyt lot 2618-0169-6447.With the exception of the non-reproducible results obtained from the affected patient samples, vitros phyt lot 2618-0169-6447 otherwise appeared to be performing within expectations.In addition, results of precision testing demonstrated that one of the vitros 5600 integrated systems was operating as expected at the time of the event.Finally, it is unknown if the affected sample was centrifuged according to the collection device manufacture¿s recommendations, therefore, improper pre-analytical sample handling cannot be ruled out as a contributing factor.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.

Event Description

A customer obtained non-reproducible vitros phyt (phenytoin) results from two different samples collected from the same patient tested on two different vitros 5600 integrated systems.On (b)(6) 2019: patient sample results of greater than 158.4, 200.0, 207.0, greater than 158.4, and greater than 158.4 umol/l vs.The expected result of 124.5 umol/l.On (b)(6) 2019: patient sample result of 97 umol/l vs.The expected result of 172.0 umol/l biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The non-reproducible vitros phyt patient sample results were not reported from the laboratory.Ortho has not been made aware of any allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (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: 8678572
• MDR Text Key: 212150036
• Report Number: 1319809-2019-00039
• Device Sequence Number: 1
• Product Code: DIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2019
• Device Catalogue Number: 8298671
• Device Lot Number: 2618-0169-6447
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1