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 Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

Customer reported a sample with known blood type of (a pos) being reported by the vision as (o pos).The sample was repeated by using manual gel and resulted a pos as expected.A second sample was collected on from the same patient and tested on a second vision which resulted in a pos.Ortho referred the customer to the ortho vision ref guide that indicates, "the ultimate responsibility for the integrity and identity of blood samples lies with trained personnel.Results obtained by the ortho vision analyzer must be clinically interpreted and validated by qualified personnel." customer retested both samples on the first vision analyzer and both resulted in a pos as expected.The root cause of this event could not be determined.No incorrect or erroneous results were reported as a result of this incident.There was no risk present at the time of the incident.There was no harm to any patient.

Event Description

Customer contacting ortho care to report an incorrect blood group of o pos being issued by the ortho vision to a patient known to be a blood group of a pos.(b)(6).Testing of the samples by manual gel and traditional tube and all tested as blood group a pos.

• 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: 7412343
• MDR Text Key: 105524672
• Report Number: 2250051-2018-00036
• 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: 04/10/2018

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: 5.10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2016
• 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