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 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined lower than expected vitros phyt results were obtained from vitros and non-vitros quality control fluids, using two different slide lots of vitros phyt slides tested on a vitros 5600 integrated system.The assignable cause for the lower than expected qc result from the mas level 1 (5.69) and all the tdm iii (l5351) results was most likely an instrument related issue.A within-run precision test was processed and the results were outside of ortho guidelines, indicating the vitros 5600 system was not performing as intended.The ortho fe performed service actions to the microslide incubator and immunorate subsystems.Following service actions, acceptable qc results were obtained indicating the vitros 5600 system was performing as expected.The assignable cause for the lower than expected qc results from the mas level 1 (5.7) and level 3 (24.64) was unknown.The customer repeated qc testing the same day and obtained acceptable results.The customer does not recall how this issue was resolved and a qc fluid issue or pre-analytical sample handling are potential contributing factors to this event.

Event Description

A customer reported multiple lower than expected vitros phyt quality control results were obtained using non-vitros mas qc fluids and vitros tdm qc fluids on two different vitros phyt slide lots tested on a vitros 5600 integrated system.Phyt lot 2616-0165-6276.Mas lot lia20040 level 1 = 5.69, 5.70 versus expected 7.8 ug/ml.Phyt lot 2616-0165-6832.Vitros tdm iii lot l5351 = 19.77, 21.21, 21.56, 21.95, 22.31 versus expected 28.5 ug/ml.Mas lot lia20040 level 3 = 24.64 versus expected 35.8 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected.The customer made no allegation that patient results were affected or reported from the laboratory; however, the investigation cannot conclude that patient samples were not affected or would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of this event.This report is number three of three mdr¿s for this event, as three 3500a forms are being submitted as three devices were involved.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: 7393987
• MDR Text Key: 104738898
• Report Number: 1319809-2018-00060
• 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: 04/03/2018
• 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: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1