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

Catalog Number 6904577

Device Problems False Negative Result (1225); Incorrect Or Inadequate Test Results (2456)

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

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

Discrepant negative antibody screening results for one patient having anti-c(rh2) and anti-e(rh5) antibodies.The most probable root-cause is sample-related, the antibodies being weak and/or at detection limit of the reagents and techniques used and/or associated with the variability of expression of the antigens present on the reagent red blood cells.No general product failure is identified.No biased result was reported to a physician.The patient was not harmed.(b)(4).

Event Description

A customer complained after obtaining what was described as discrepant negative antibody screening result for one patient using the ortho biovue system in conjunction with their ortho vision biovue analyser.Complainant: ms.(b)(6) ¿ position not provided.Complaint reporter: mr.(b)(6) ¿ ortho field engineer.Date of events: (b)(6) 2017, (b)(6) 2017.Reported on: (b)(6) 2017 by ms.(b)(6) to mr.(b)(6) who reported it to the ortho helpdesk on the same day (b)(6) 2017 by ms.(b)(6) to ortho helpdesk.Reagents: ortho biovue system poly cassette lot ahc045f exp.10 april 2018; 0.8% surgiscreen lot 8ss350 exp.31 october 2017; bio-rad poly cards lot number and expiry date not provided; bio-rad 0.8% red cell panel lot number and expiry date not provided.Software version: 4.8.0.Patient information: female patient (sample id: (b)(6)); pregnant; known to have an anti-e(rh5) antibody.No further information provided.The complaint reporter said that, on (b)(6) 2017, the customer had tested a patient sample for antibody screening in indirect antiglobulin test (iat) technique using ortho biovue system poly cassette and 0.8% surgiscreen in conjunction with their ortho vision biovue analyser and that they had obtained negative reactions with the 3 cells of the red cell reagent.The complaint reporter said that, on the same day, the customer had retested the same patient sample for antibody screening in iat technique using bio-rad technique and that they had obtained positive reactions with cells 1 and 4 (with a 1+ reaction strength) and negative reactions with cells 2 and 3 of the red cell reagent.The customer said that they were able to identify an anti-c(rh2) antibody.No further information was provided.The complaint reporter said that, on (b)(6) 2017, the customer had retested the same patient sample for antibody screening in iat technique using ortho biovue system poly cassette and 0.8% surgiscreen in conjunction with their ortho vision biovue analyser and that they had obtained negative reactions with the 3 cells of the red cell reagent.The customer reported that no biased result had been reported to a physician and that the patient 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
• Manufacturer Contact: matthew p wictome ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 7049294
• MDR Text Key: 93758430
• Report Number: 2250051-2017-00097
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6904577
• Device Lot Number: 4.8.0
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1