MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS ECI IMMUNODIAGNOSTIC SYSTEM; CHEMISTRY ANALYZER

Catalog Number 8633893

Device Problem Patient Data Problem (3197)

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

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that results for two different patient samples were associated with the incorrect sample id (sid) when run on a vitros eci immunodiagnostic system.The assignable cause of the event was user error when entering a sid number into the system.The customer erroneously entered a sid number into the system that had no corresponding physical sample.The sample program for this sid remained in the memory of the vitros eci immunodiagnostic system.Two different operators on two separate dates erroneously entered the retained sid number for samples which had alternative sid numbers.When each of these samples were processed, the results were mis-associated with the retained sample id number.The customer confirmed that the issue was due to user error and that no erroneous results were reported out of the laboratory.The vitros 5600 integrated system did not malfunction.

Event Description

A customer reported that results for two different patient samples were associated with the incorrect sample id (sid) when run on a vitros eci immunodiagnostic system.The customer identified the discrepancy and no erroneous results were reported.There was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).

• Brand Name: VITROS ECI IMMUNODIAGNOSTIC SYSTEM
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9883789
• MDR Text Key: 218738396
• Report Number: 1319681-2020-00016
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8633893
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2000
• 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