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

Catalog Number 6904577

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/13/2022

Event Type  malfunction  

Event Description

Customer reported that on (b)(6) 2022, one sample was tested on vision and results showed the blood type as group b rh positive, but when sample was tested via manual tube method, the blood showed as group a, rh negative repeated testing using a new sample and manual tube method, the blood type showed as group a, rh negative customer contacted ortho care: rollover message taken by (b)(4) on (b)(6) 2022.Complainant/complaint reporter: (b)(6)/ medical technologist.Awareness date: (b)(6) 2022.Event date(s): (b)(6) 2022.Analyzer(s): ortho vision id-mts/ (b)(4) (used for troubleshooting).Software version: 5.13.2.47027.Reagents: mts abd mono/rev card lot# 031022037- exp 18dec2022.0.8% affirmagen lot# a437 exp 28jun2022.Patient information: 75 years old.Sample id: (b)(6).The customer reported that no biased result was reported to a physician.The customer reported that the patient was not harmed because of the reported events.

Manufacturer Narrative

(b)(4).Discrepant positive b and d antigen typing result for one patient.The assignable cause of the discordant positive b and d antigen typing results for one patient was determined to be associated with a user error, the operator having loaded using the hand scanner, a sample barcode assigned to sample position #3 id as (b)(6).Vision tested position #3 as the hand scanned assigned (b)(6).It is suspect that sample (b)(6) was placed in position 2 by user and another samples was tested in 3.No general product failure is identified.No biased result was reported to a physician.The patient was not harmed.See (b)(4) for root cause investigation.Recall identifier# (b)(4).

• Brand Name: ORTHO VISION ID-MTS ANALYZER
• Type of Device: AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 14497586
• MDR Text Key: 300557962
• Report Number: 2250051-2022-00040
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6904577
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2022-06
• Patient Sequence Number: 1