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

Catalog Number 8298671

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros phyt results were obtained from a vitros performance verifier fluid using vitros phyt slide lot 2616-0165-6787 on a vitros 5600 integrated system s/n (b)(4).A definitive assignable cause could not be determined, however, a sub-optimal calibration event is the most likely cause.The calibration that generated the higher than expected results had responses and parameters that appeared atypical to expected responses and parameters.In addition, vitros phyt slide lot 2616-0165-6787 cannot be ruled out as contributing to the event.Historical quality control results indicated the presence of within-lab imprecision associated with vitros phyt results at the concentration of tdm pv iii.Ortho currently has an investigation open for an increase in complaint rate for higher than expected quality control and patient results, and imprecision, using phyt coating 0165.The issue was resolved when an alternate phyt slide lot (coating 0166) was put into use.There was no indication that an instrument related issue contributed to the event.As the quality control results were not acceptable patient samples were not tested during this time, and there were no allegations of patient harm.However, the investigation cannot conclude patient results would not be affected if the event were to recur undetected.

Event Description

A customer obtained higher than expected vitros phyt results for a vitros theraputic drug monitoring performance verifier (tdm pv) fluid, when compared to the expected mean result.The results were generated using vitros chemistry products phyt slides processed on a vitros 5600 integrated system.Vitros tdm iii lot x6157 results 148.3, 145.1, 142.4 and 136.1 umol/l vs.Expected result of 110.1 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected.Ortho was not made aware of any allegation of patient harm due to the event.However the investigation cannot rule out that patient results were not or would not be affected if the event were to recur undetected.(b)(4).This report is number two of four mdr¿s for this event.Four 3500a forms are being submitted for this event as four devices were involved.

Event Description

This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

Manufacturer Narrative

A potential issue related to the absolute response rates and the dose response curve of phyt coating 0165 is being investigated.The fda¿s new york district office was notified of this issue on 16 may 2018.Please refer to report # 1319809-05/18/2018-001.

• 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
• MDR Report Key: 7457324
• MDR Text Key: 107096838
• Report Number: 1319809-2018-00070
• Device Sequence Number: 1
• Product Code: DIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Catalogue Number: 8298671
• Device Lot Number: 2616-0165-6787
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1