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

Catalog Number 6904578

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

Discrepant negative grading in crossmatch testing for one patient sample.The root-cause could not be determined.No general product failure was identified.No biased result was reported to the physician.No patient was harmed.

Event Description

A customer complained after obtaining what was described as a discordant negative grading of a reaction in a crossmatch test for a patient using ortho biovue system in conjunction with their ortho vision max biovue analyzer.Complainant/ complaint reporter: dr.(b)(6) ¿ medical director.Reported on: 12 april 2018 by dr.(b)(6) to ortho care helpdesk.Event date: (b)(6) 2018.Software version: 5.10.0.Reagents: ortho biovue system anti-igg cassette lot igc700a expiry date 27 june 2018 patient information: patient is a (b)(6) male with a diagnosis of gastrointestinal haemorrhage and chronic kidney disease.The patient is blood group b rhd positive with anti-e(rh3), anti-mia and anti-fya (fy1) antibodies.The patient has an auto-antibody in addition to allo-antibodies.On the (b)(6) 2018 the patient had a positive antibody screening with a positive reaction in all 3 cells of the red cell reagent, and a positive (3+ reaction strength) for dat (direct antiglobulin test).The customer said that on (b)(6) 2018, they tested a patient sample and donor for a major crossmatch test in iat (indirect antiglobulin test) using ortho biovue system anti-igg cassette in conjunction with their ortho vision max biovue analyser and that they had obtained a negative/compatible reaction.The customer was expecting a positive/incompatible reaction and said that the reaction in column 5 looked weakly positive on visual inspection.The customer reported that no biased result had been reported to a physician and that the patient concerned had not been harmed as a result of the reported event.

• Brand Name: ORTHO VISION MAX ID-MTS
• Type of Device: AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer Contact: matthew p wictome ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 7506395
• MDR Text Key: 108646649
• Report Number: 2250051-2018-00051
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6904578
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1