MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK; IN VITRO DIAGNOSTICS

Catalog Number 1387000

Device Problem Low Test Results (2458)

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

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected vitros ft4 results were obtained from two different patient samples when using vitros immunodiagnostic products ft4 reagent on two different vitros 5600 integrated systems.The assignable cause for the lower than expected vitros ft4 results could not be determined.Based on historical quality control results, a vitros ft4 lot 4290 performance issue is not a likely contributor to the event.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ft4 reagent lot 4290.Vitros tsh precision testing performed on one of the vitros 5600 integrated systems was within ortho acceptable guidelines suggesting an instrument issue was not likely a contributing factor.Although precision testing was not completed on the other vitros 5600 integrated system, there was no indication that the analyzer was a contributor to the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was established that the customer was not following the sample collection device manufacturer¿s recommendation for sample centrifugation.Improper pre-analytical sample handling could have contributed to this event.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 contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report lower than expected vitros ft4 results obtained from two different patient samples when using vitros immunodiagnostic products ft4 reagent on two different vitros 5600 integrated systems.Patient sample 1 result of 1.85 ng/dl versus the expected result of 2.40 ng/dl.Patient sample 2 results of 1.73 and 2.15 ng/dl versus the expected result of 2.77 ng/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros ft4 results were reported from the laboratory to a physician.However, no treatment was altered, initiated or stopped based on the reported result and a corrected report was later issued for the samples.There were no allegations of patient harm as a result of this event.This report is number 2 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9224644
• MDR Text Key: 220786304
• Report Number: 3007111389-2019-00166
• Device Sequence Number: 1
• Product Code: CEC
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2020
• Device Catalogue Number: 1387000
• Device Lot Number: 4290
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2019
• 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