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

Catalog Number 1922814

Device Problem Patient Data Problem (3197)

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

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that the sample ids for two different patient samples were associated with the incorrect patient names when processed on a vitros eciq immunodiagnostic system.The most likely cause of the event was user error.The customer reused sids without ensuring the previously programmed sids were processed to completion or deleted prior to reuse.The vitros eciq immunodiagnostic system was operating as intended.The tsc explained to the customer that the cause of the event was likely due to improper reuse of an sid without ensuring that the previous program associated with the sid was processed to completion or deleted prior to reuse.The tsc reviewed with the customer how to properly manage sid numbers that were previously used and not processed to completion or deleted.The tsc also reviewed with the customer how to delete old sid numbers from the vitros system.The customer is aware of ortho¿s recommendations on how to properly manage sid numbers.The customer understood that the root cause of the mis-associated patient results was user error due to improper reuse of a pending sid and agreed to delete pending sample ids from the sample programming interface of the vitros eciq instrument on a regular basis.

Event Description

A customer contacted the ortho clinical diagnostics (ortho)technical solutions center (tsc) because they identified results for two different patient samples that were mis-associated with the incorrect patient names when run on a vitros eciq immunodiagnostic system.Based on the events described by the customer, the issue appeared to be consistent with the reuse of a sample id (sid) that was previously programmed for an alternate patient sample that was not processed to completion.The customer confirmed that the site does reuse sids and agreed that the scenario above is what likely caused the event.If a retained sid is reused at a later date for a different patient sample, the following will occur: the original sid and its associated program, including tests and demographics, are stored in the system memory indefinitely.If a new sample is processed in the future using the same retained sid, the tests and demographics associated with the new sample program will not be stored in the system memory.After processing the new sample for the pending tests, the results obtained are associated with the patient demographics for the original retained sample program.Test results could have been misreported out of the laboratory leading to inappropriate intervention with the potential for serious injury to the patient.However, the customer identified the discrepancy and no mis-associated patient results were reported out of the laboratory.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (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
• 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: 9510639
• MDR Text Key: 219781079
• Report Number: 1319681-2019-00092
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2009
• 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