MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS ORTHO VISION ID-MTS; AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM

Catalog Number 69045777

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

Discordant abo blood groups for 2 patients.The root-cause of is associated to a use error, a laboratory operator having performed an incorrect sample assignment using the hand scanner.No general product failure is identified.Unknown if biased results were reported to the physicians.The patients were not harmed.(b)(4).

Event Description

A customer contacted ortho care on 08 october 2021 after obtaining what was described as discordant abo blood group results for two patients using their ortho vision id-mts analyzer.Events date: (b)(6) 2021.Complainant/complaint reporter: (b)(6) ¿ laboratory supervisor.Reported on 08 october 2021 by (b)(6) to ortho care reagents: n/ap.Software version: 5.12.4.Patients¿ information: not provided.The customer reported that, on (b)(6) 2021, they had tested 2 patients for abo grouping in conjunction with their ortho vision id-mts analyzer and that they were suspecting abo discrepancies for these 2 patients.No further detail was provided.It is unknown if biased results had been reported to the physicians.The information was requested but not provided by the customer.The customer reported that the concerned patients had not been harmed as a result of the reported events.

• Brand Name: ORTHO VISION ID-MTS
• Type of Device: AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• MDR Report Key: 12666194
• MDR Text Key: 284189533
• Report Number: 2250051-2021-00060
• Device Sequence Number: 1
• Product Code: KSZ
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 69045777
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1