MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS, INC. RED BLOOD CELL DILUENT MTS DILUENT 2; MEDIA, POTENTIATING FOR IN VITRO DIAGNOSTIC USE

Lot Number MD142

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 09/23/2020

Event Type  malfunction  

Event Description

The bottles of mts diluent 2 and mts diluent 2 plus look nearly identical making it easy to inadvertently select the wrong bottle of diluent.This has potential to cause an important medical event.

• Brand Name: RED BLOOD CELL DILUENT MTS DILUENT 2
• Type of Device: MEDIA, POTENTIATING FOR IN VITRO DIAGNOSTIC USE
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS, INC.
• MDR Report Key: 10843806
• MDR Text Key: 216632037
• Report Number: MW5097895
• Device Sequence Number: 2
• Product Code: KSG
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/12/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/03/2021
• Device Lot Number: MD142
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other