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 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that lower than expected, non-reproducible vitros phyt results were obtained from the same patient sample processed on two different dates processed on a vitros 5600 integrated system.The likely cause of the two lower than expected, non-reproducible phyt results is unknown, but is isolated to testing of one specific patient sample.The acceptable historical vitros phyt quality control results and the acceptable within run vitros phyt precision test results indicate that vitros phyt lot 2616-0165-6832 in combination with the vitros 5600 system is performing as expected.There is no evidence that the vitros 5600 system or vitros phyt lot 2616-0165-6832 caused the two low phyt outlier results.In addition, user error related to pre-analytical sample handling cannot be ruled out as contributing to the event.It is unknown if the customer is following the manufacturer recommendations for centrifuge spin time.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

The customer observed lower than expected, non-reproducible vitros phyt results that were obtained from the same patient sample processed on two different dates tested on a vitros 5600 integrated system.On (b)(6) 2018 patient sample result = 8.9 ug/ml versus an expected result of 19.7 ug/ml.On (b)(6) 2018 patient sample result = 5.2 ug/ml versus an expected result of 15.9 ug/ml.Biased patient results of the direction and magnitude observed may lead to inappropriate physician action if occurred undetected.The lower than expected (b)(6) 2018 patient sample result of 8.9 ug/ml was initially reported from the laboratory and questioned by a physician and a corrected report was issued.The lower than expected (b)(6) 2018 patient sample result of 5.2 ug/ml was not reported outside of the laboratory.There was no allegation of patient harm.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

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: 7506129
• MDR Text Key: 108646096
• Report Number: 1319809-2018-00081
• 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: health professional
• 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: 05/11/2018
• 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: 2616-0165-6832
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1