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

Catalog Number 6904577

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/19/2017

Event Type  malfunction  

Manufacturer Narrative

R and d analyzed the imaged provided by the customer and indicated that the instrument performed as expected.The reaction seen on the card met the criteria for 1+.The customer has the option to set up the vision system to enable cards below the threshold to be sent to the service rack, in this incident, this option was not enabled.Due to the sample being cord blood, reverse testing was not performed and final results were not manually reviewed.The investigation determined that the most likely root cause of this event was sample related.

Event Description

Account reports a cord blood tested on(b)(6) 2017 where they got a 1+ result on the vision for the forward type a microtube.Account had vision set to automatically accept results - since they did not get a question mark a positive was reported as the type and card did not come to the manual review rack.Site contact likes to review 1+ results so the next day she saw the image - there appears to be some fibrin or something above the negative red cell button.Image will be attached.Raw image not available as testing was conducted over 28 days ago.She repeated testing in tube on the bench and got the correct result as o positive.A corrected report was released at that time.No harm came to the baby.

• Brand Name: ORTHO VISION
• 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: 7053866
• MDR Text Key: 93599401
• Report Number: 2250051-2017-00098
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 11/22/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6904577
• Device Lot Number: 4.8.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• 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