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

Catalog Number 1922814

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2021

Event Type  malfunction  

Event Description

The investigation determined that results obtained from an un-named negative quality control sample were mis-associated with a patient sid processed on a vitros eciq immunodiagnostic system.No specific results were provided by the customer.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The customer identified the discrepancy and no erroneous results were reported.The vitros eciq immunodiagnostic system was operating as intended and did not malfunction.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4).

Manufacturer Narrative

The investigation determined that results obtained from an un-named negative quality control sample were mis-associated with a patient sid processed a vitros eciq immunodiagnostic system.The assignable cause of the event was determined to be user error.The customer placed the negative quality control sample into a sample tray position that had been previously manually programmed for a patient sid and assay requests.The patient sample was successfully processed the previous day and all assay requests had results, which were reported outside of the laboratory.The vitros operator did not delete the duplicate manually assigned sid program from the sample tray position, therefore it was retained in the pending sample programming data base on the system.(b)(4).

• Brand Name: VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 11775781
• MDR Text Key: 280692640
• Report Number: 1319681-2021-00049
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1922814
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1