MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS ECI IMMUNODIAGNOSTIC SYSTEM REFURBISHED; IMMUNODIAGNOSTIC SYSTEMS

Catalog Number 6801059

Device Problem Patient Data Problem (3197)

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

Event Date 12/06/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that the sample ids (sids) for two different patient samples were associated with the incorrect patient names and assay results when processed on a vitros eci immunodiagnostic system.The cause of the event was user error due to improper sid reuse.The customer reused sids without ensuring the previously programmed sids were processed to completion or deleted prior to reuse.If a sample is not processed to completion, the sample programming and associated demographics data are retained by the analyzer in a "pending" state, as per the design of the software.Re-using the same sid on a different sample without completion of the original request or deletion of the pending testing will cause the original information to be carried forward.The vitros eci immunodiagnostic system was operating as intended.Email address for contact office above is (b)(6).

Event Description

The customer reported that they identified results for two different patient samples that were mis-associated with the incorrect patient names and assays when processed on a vitros eci immunodiagnostic system.This event could lead to mis-associated patient results, which may lead to inappropriate physician action if it were to occur undetected.The customer identified the discrepancy prior to reporting the results from the laboratory.There is no allegation of patient harm related to this event.This report corresponds to ortho clinical diagnostics inc.(b)(4).

• Brand Name: VITROS ECI IMMUNODIAGNOSTIC SYSTEM REFURBISHED
• Type of Device: IMMUNODIAGNOSTIC SYSTEMS
• 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: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11028336
• MDR Text Key: 222794344
• Report Number: 1319681-2020-00124
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: RQ
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6801059
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2007
• 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