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 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that multiple non-reproducible, lower than expected vitros phyt results were obtained from multiple patient samples on two vitros 5600 integrated systems.A likely assignable cause for the lower than expected vitros phyt results could not be determined, however, an unexpected instrument, a reagent issue, or user error due to inappropriate pre-analytical sample handling cannot be ruled out as contributing factors.The within run phyt precision testing was unacceptable, indicating the instrument was not performing as intended, however repeat within run phyt testing was acceptable without changing the state of the analyzer.Therefore the vitros 5600 system contribution to the event could not be ruled out or confirmed.Based on review of historical quality control, there was no indication the vitros phyt microslide reagent lot 2614-0158-8794 malfunctioned.No quality control results were provided for the alternate reagent lot 2614-0158-8775, used on the vitros j2 system, therefore, although there is no evidence the reagent lot malfunctioned, it cannot be ruled out as a contributing factor to the event.Pre-analytical sample processing could not be ruled out as a contributing factor, as the customer was unable to provide information regarding the specific centrifugation conditions used to pre-analytically handle the patient sample in question, therefore it is unknown if they are following the sample device manufacturer¿s recommended guidelines for sample centrifugation.Cellular debris, due to poor sample preparation, may have been present in the affected sample, although this could not be confirmed.

Event Description

A customer obtained multiple non-reproducible, lower than expected vitros phenytoin (phyt) results from multiple patient samples processed using vitros chemistry products phyt slides on two vitros 5600 integrated systems (j1 and j2).J1: vitros phyt reagent lot 2615-0158-8794.Patient: vitros result 3.4 and 4.6 ug/ml vs.The expected result of 10.9 ug/ml.Patient: vitros result 6.1 ug/ml vs.The expected result of 12.9ug/ml.Patient: vitros result 11.0 ug/ml vs.The expected result of 16.3 ug/ml.Patient: vitros result 3.3 and 8.2ug/ml vs.The expected result of 10.9 ug/ml.Patient: vitros result 16.2 and 23.4 ug/ml vs.The expected result of 35.7ug/ml.Patient: vitros result 3.0 and 3.0 ug/ml vs.The expected result of 24.7ug/ml.Patient: vitros result 12.5 ug/ml vs.The expected result of 16.3ug/ml.Patient: vitros result 3.0 ug/ml vs.The expected result of 7.5ug/ml.Patient: vitros result 3.0 ug/ml vs.The expected result of 7.5ug/ml.Patient: vitros result 9.4ug/ml vs.The expected result of 25.2 ug/ml.J2: vitros phyt reagent lot 2615-0158-8775 patient: vitros result 27.7 ug/ml vs.The expected result of 35.7ug/ml.Patient: vitros result 3.0 and 3.0 ug/ml vs.The expected result of 24.7ug/ml.Patient: vitros result 11.3 ug/ml vs.The expected result of 16.3ug/ml.Patient: vitros result 3.0 ug/ml vs.The expected result of 7.5ug/ml.Patient: vitros result 5.3 ug/ml vs.The expected result of 25.2 ug/ml.The customer reported the result for patient a (3.4 ug/ml) to the clinician; however, the higher than expected result was questioned by the clinician and the corrected report was released.No additional results were reported from the laboratory, as the additional patient samples were tested for investigation purposes only.Ortho has not been made aware of any allegations of actual patient harm occurring as a result of the events.This report is number nineteen of twenty mdr's for this event.Twenty 3500a forms are being submitted for this event as twenty 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: 5664714
• MDR Text Key: 46671496
• Report Number: 1319809-2016-00061
• 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: 05/18/2016

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: 05/15/2016
• Device Catalogue Number: 8298671
• Device Lot Number: 2615-0158-8775
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1